Job Search Results for medical device regulations

COPY - Project Manager (INTL - Mexico)

Insight Global is seeking a Project Manager to support our Medical Device client. This consultant will sit remotely in Mexico and should have experience in a medical device environment, ideally... More supporting Quality Systems?related initiatives. This role will manage multiple, overlapping projects and work closely with senior stakeholders to drive execution and visibility. Day to day will consist of the following: Responsibilities-Manage multiple concurrent projects within a regulated medical device environment-Coordinate and communicate with senior-level stakeholders across teams-Develop and maintain project plans, timelines, and status updates-Prepare and coordinate slides, decks, and executive-ready presentations-Track risks, dependencies, and deliverables across initiativesCompensation: $16/hr to $20/hr. Exact compensation may vary based on several factors, including skills, experience, and educationWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Clinical Research Specialist

A large medical device company in Irvine, CA is looking for a Clinical Research Specialist. This candidate will play a crucial role in supporting a 10 year post market clinical trial for breast... More implants. Their key responsibilities will include monitoring clinical studies, data verification, regulatory compliance, study documentation, site visits and coordination, and developing written travel reports.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Customer Service Representative - INTL Brazil

Our large Medical Device company is seeking a Customer Service Representative for their Complaint Handling department. This position provides contact center support for complaint handling and is... More responsible for adherence to department procedures, country specific privacy and regulatory guidelines while meeting customer expectations with a focus on overall customer experience and retention. Responsibilities Include: -Evaluates and resolves product complaints worldwide per FDA, ISO, SOX, and other applicable regulatory requirements. -Monitors feedback activity using CHS and SAP systems to provide complaint resolution and promote customer satisfaction. -Documents files accurately.-Positively interacts with customer, providing education, product and service information and resolution. -May be responsible for actively monitoring workflow and ensuring complaints are closed in accordance with established MD&D and departmental metrics. -May be responsible for additional administrative and technical tasks, including PO generation and monitoring, IT help desk requests and call center telephony support.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Head of Sales

The Head of Sales is responsible for leading the U.S. commercial sales organization to achieve revenue growth, market expansion, and profitability objectives. This role develops and executes the... More national sales strategy, builds a high-performing sales organization, and collaborates closely with Marketing, Clinical Affairs, Operations, and Executive Leadership to drive sustainable business growth. The ideal candidate has a proven track record of leading medical device sales teams, developing commercial strategies, and consistently exceeding sales targets within a highly regulated healthcare environment.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Regional Sales Manager (Southern California) - Remote

Position OverviewPAE is seeking a high-performing Regional Sales Manager to drive net-new business across Southern California. This is a true hunter role focused on identifying, developing, and... More winning new manufacturing opportunities. Candidates must be comfortable building a territory from scratch, creating pipeline through prospecting, and managing long-cycle technical sales opportunities from prototype through full production.This is not an account management role. The ideal candidate combines strong business development instincts with the technical credibility required to engage engineers, sourcing teams, procurement leaders, and manufacturing stakeholders.Key ResponsibilitiesDevelop and execute a territory growth strategy focused on net-new customer acquisition.Identify and pursue target accounts within medical device, industrial, electronics, and manufacturing sectors.Prospect engineers, buyers, sourcing managers, procurement leaders, and operations stakeholders.Drive opportunities from discovery through prototype, NPI, and production awards.Conduct onsite customer visits and technical sales presentations.Build and maintain a robust pipeline of strategic manufacturing opportunities.Partner with engineering and operations teams to ensure successful program execution.Convert prototype and NPI projects into long-term production contracts.Maintain accurate forecasting and pipeline management within CRM tools.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

SAP Functional Consultant ? INTL Brazil

OverviewWe are seeking an experienced SAP Functional Business Partner to support the transition from legacy ERP systems to SAP R/3 across multiple medical device manufacturing sites.This role is... More highly business-facing and consultative, focused on partnering with site stakeholders to understand current processes, drive standardization, and design future-state SAP solutions. The individual will act as a bridge between manufacturing operations, business teams, and IT, providing functional direction to technical teams throughout the transformation.This is not a hands-on configuration role?it is focused on process design, solution definition, and stakeholder partnership.Key Responsibilities?Act as a business partner to manufacturing sites, including supply chain and IT teams?Support the transition from legacy ERP systems to SAP R/3, ensuring alignment to business and operational needs?Lead current-state assessments and future-state process design across plant operations?Facilitate workshops and discovery sessions to identify gaps, inefficiencies, and opportunities for standardization?Define SAP-aligned solutions that meet both business requirements and regulatory considerations?Translate business requirements into clear functional specifications for technical (ABAP/integration) teams?Provide ongoing guidance to technical teams during solution design and build phases?Ensure alignment across Finance (FICO), Procurement (MM), and Warehouse Management (WM) processes?Support testing, validation, and deployment activities, particularly within regulated manufacturing environments?Drive adoption of best practices and simplified, standardized processes across sitesWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Senior Quality Engineer -- INTL Philippines

Our client is seeking a Senior Quality Engineer to support global quality initiatives across a growing mechanical manufacturing organization. While the company's core business has historically been... More centered around cable manufacturing, they are experiencing significant growth in CNC machining, surface treatment, and precision mechanical components due to increased demand and an expanding portfolio of projects with key customers. This role will be instrumental in supporting that growth by ensuring robust quality processes, supplier performance, and compliance across global operations. This individual will serve as a subject matter expert in quality engineering, supplier quality, metrology, GD&T, and manufacturing quality systems. They will play a critical role in validating products and processes, conducting technical reviews, developing suppliers, driving corrective actions, and ensuring compliance with stringent quality requirements, particularly within medical device and automotive environments. The ideal candidate will bring a strong mechanical manufacturing background, extensive supplier quality experience, and the ability to influence suppliers and internal stakeholders across a global organization.Job Responsibilities: ?Lead technical quality reviews for new products and manufacturing processes?Validate product and process readiness for production launches and customer programs?Review mechanical drawings, specifications, and GD&T requirements to ensure manufacturability and quality compliance?Serve as the quality subject matter expert for mechanical components and assemblies?Partner with suppliers to improve process capability, quality performance, and compliance with customer requirements?Conduct supplier qualification assessments, audits, and ongoing performance evaluations?Lead root cause investigations and corrective actions for supplier and customer quality issues?Analyze dimensional data, measurement methods, and process capability studies to identify quality risks?Support new product introduction (NPI) activities and customer project launches?Develop, coach, and mentor suppliers on quality systems, inspection methodologies, and continuous improvement initiatives?Collaborate with engineering, supply chain, manufacturing, and customer teams to resolve complex quality challenges?Ensure compliance with ISO 13485, IATF 16949, ISO 9001, and applicable customer quality requirements?Support strategic projects involving CNC machining, surface treatment, and precision mechanical manufacturing?Participate in customer audits, supplier audits, and quality system assessments?Travel to supplier and customer locations as necessary to support quality initiatives and project successWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Snowflake Administrator ? INTL India

Insight Global is seeking two experienced Snowflake Administrators for one of our large healthcare/medical device clients. This consultant will join the data platform team in support of key... More enterprise initiatives, including ongoing global wave rollouts and hypercare activities. This is an offshore, 6-month contract engagement with potential for extension based on business needs and performance. The administrators will play a critical role in maintaining platform stability, optimizing performance, and ensuring seamless data operations across the organization.The ideal candidates are self-driven, accountable, and thrive in a fast-paced, operationally demanding environment where system uptime and reliability are paramount.Key Responsibilities- In this role, you will serve as a core administrator for the Snowflake environment, working alongside an existing US-based administrator to provide near 24/7 coverage. A typical day may include:- Platform administration: Managing users, roles, and access controls (RBAC); provisioning and de-provisioning accounts; ensuring proper grants and permissions.- Warehouse management: Monitoring warehouse usage, optimizing sizing based on peak vs. off-peak demand, and tuning performance to ensure efficient query execution.- Security & governance: Implementing and maintaining security best practices, networking configurations, and data governance policies.- Monitoring & troubleshooting: Proactively identifying system issues, resolving incidents quickly to prevent job failures or business disruptions, and supporting the team during hypercare periods around major go-lives.- Cost optimization: Analyzing resource consumption and recommending strategies to reduce spend without compromising performance.- Documentation: Creating and maintaining Standard Operating Procedures (SOPs) and best practice guides for the platform.- Collaboration: Working closely with data engineering, integration, and business teams to support data flows across source systems (SAP, D365/DBX, and others) into Snowflake.- On-call support: Providing coverage during off-hours when critical issues arise, with an overlap/handshake model between offshore and US shifts.The role is not consistently high-volume, but does require flexibility and responsiveness during critical periods such as go-lives, wave deployments, and hypercare windows.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Sr Instructional Designer

? Partner with SMEs to gather and understand training content? Convert existing materials into eLearning modules and learning assets? Develop engaging courses utilizing Articulate Rise and Storyline... More 360? Ensure content remains compliant and aligned with source materials? Create videos and digital learning experiences using modern learning technologies? Support training initiatives for a highly regulated healthcare environment? Collaborate with stakeholders to revise and enhance learning content? Maintain instructional design best practices throughout developmentJob Description:Insight Global is seeking an Instructional Designer for a leading medical technology client. This individual will be responsible for partnering closely with SMEs to transform existing training materials into engaging, high-quality digital learning experiences. The ideal candidate will have strong experience developing eLearning content using Articulate Rise and Storyline 360 and will be comfortable working within established content frameworks while ensuring accuracy and compliance. Experience within highly regulated environments, such as medical devices, healthcare, pharmaceuticals, or FDA-regulated industries, is highly preferred. This is a long-term remote opportunity supporting a collaborative team focused on delivering impactful learning solutions across their users.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Copy Approval Specialist

Insight Global is looking for a Copy Approval Specialist for a long-term contract opportunity that can sit remotely working EST hours. The Copy Approval Specialist serves as the first point of... More contact in the content review process. This individual will partner closely with the Professional Education content owners and business stakeholders to ensure their educational content and materials are properly prepared, submitted, and advanced through the review and approval process. Working across Spine, Sports, and CMF this role helps maintain compliance standards while ensuring educational materials are delivered accurately and on schedule.Key Responsibilities?Serve as the initial coordinator for Professional Education content submissions prior to formal review and approval.?On a weekly basis, this individual will be partnering with the team to submit assets to copy approval through AMP (Asset Management Platform) for approval?Partner with content owners, marketers, and Professional Education stakeholders to prepare educational materials for review.?Ensure submissions are complete, properly documented, and aligned with established content review requirements before entering the approval process.?Manage the intake, tracking, routing, and status of educational content throughout the review lifecycle.?Coordinate revisions and follow-up actions between content creators and reviewers to help content progress efficiently through review cycles.?Maintain content records, submission documentation, approval histories, and supporting materials.?Monitor review timelines and proactively communicate upcoming deadlines, bottlenecks, and outstanding actions to stakeholders.?Support the management of educational assets, presentations, training materials, and related Professional Education content.?Collaborate with Marketing, Professional Education Managers, Medical Affairs, Regulatory, Legal, and Compliance teams to facilitate content approvals.?Provide administrative and operational support for content systems, workflows, and reporting used within the Professional Education organization.It is important that this employee possess excellent and professional communication (both written & verbal), project management, high attention to detail and organizational skills. To be successful, they must be highly detail-oriented, able to thrive in tight deadline situations and maintain collaborative working relationships. Navigating relationships with internal groups that have different agendas but are integral to the success of the job or team is critical to success. Ability to adapt to the Global Education team?s set processes as well as be proactive in identifying and leading projects that will provide value or efficiencies to the Professional Education team. The work schedule is primarily business hours on Eastern time, with some flexibility required based on high priority needs. Occasional evenings and occasionally weekends may be required.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less