Job Search Results for medical device regulations

Insight Global is seeking a Quality Engineer to support a leading medical device manufacturer?s Cardiology division, focused on identifying actionable root causes and implementing effective solutions... More for high-visibility issues impacting Active Implantable and Accessories product performance. This role is ideal for a technically curious engineer looking to build leadership, complex problem-solving, and project management experience while leading cross-functional investigations into design-related product performance issues, including NCEPs, CAPAs, and potential field actions. The Quality Engineer will collaborate closely with Research & Development, Regulatory, Manufacturing, Medical Safety, Marketing, Post-Market, and other Quality teams, leveraging structured problem-solving methodologies to drive compliant, well-documented outcomes, support risk management, new product development, and sustainment activities, and uphold the highest standards of patient safety and product quality.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

Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint... More remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.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

Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint... More remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.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

Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint... More remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.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

We are seeking a mid-level Systems Analyst / PACS Administrator to support a major enterprise transformation effort. This role will play a critical part in maintaining and optimizing medical imaging... More systems while contributing to large-scale initiatives, including a multi-year program running through 2029 and the implementation of new enterprise platforms.This individual will help keep day-to-day imaging operations running smoothly while supporting ongoing modernization projects and future hospital expansion efforts.Key Responsibilities:Administer and support PACS and medical imaging applications in a large healthcare environmentConfigure, maintain, and troubleshoot imaging systems including:Fuji SynapseAGFA CardiologySupport application build, configuration, and optimization for imaging workflowsAssist with infrastructure and construction-related imaging initiatives, including:New device installationsImaging equipment relocationsExpansion of imaging capabilities across facilitiesMonitor and maintain system performance to ensure:Image availabilityWorkflow continuityMinimal downtime for clinical usersTroubleshoot integration and workflow issues across imaging ecosystemProvide support and coordination for enterprise initiatives, including:ServiceNow implementationEpic ?Refuel? programIntelliRad implementationCollaborate with cross-functional teams including:IT infrastructureClinical imaging teamsProject teams supporting enterprise rolloutsWe 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

Insight Global is looking for an employee for a long-term contract opportunity . They will be supporting the Promotional Integrity team at one of our largest Medical Device companies. On a weekly... More basis, this individual will be partnering with the team to submit assets to copy approval through their compliance workflow tool for approval. They will manage the copy approval process from start to finish including submitting the original asset with the appropriate linked references and links, attend meetings with Copy approval colleagues to understand requested changes, communicate 1:1 with copy review team members as needed to talk through specific changes outside of the copy approval meetings, work to relay requests to MPEs, and resubmit for approval. The individual will also need to ensure all assets have the most updated branding. In addition, this role requires the individual to manage and update assets on both internal and external platforms. 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

A large medical device client of ours is looking for an Analytical Chemist to join their NMR spectroscopy team. This individual will apply Nuclear Magnetic Resonance Spectroscopy techniques to... More support research and development, identify trace unknown impurities in complex polymer matrices, degradation products of polymer systems, small molecule/polymer interaction products, conduct extractable/leachable studies, maintain Nuclear Magnetic Resonance Spectrometer, Interpret test results and author scientific reports, and collaborate with inter-disciplinary colleagues such as toxicologists, engineers, polymer chemists, etc.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

Insight Global is seeking a detail-oriented and motivated Microbiology Laboratory Technician to join an established medical device company in Mundelein, IL. This role involves performing... More microbiological testing and analysis in support of medical device production. The ideal candidate will have a strong foundation in aseptic techniques and regulatory compliance and be comfortable working both independently and collaboratively in a fast-paced lab environment.Responsibilities: Conduct routine microbiological testing including environmental monitoring, bioburden, and endotoxin testing, specifically USP , , testing.Prepare and maintain culture media, reagents, and laboratory equipment.Document and analyze test results in accordance with GMP and GLP standards.Support investigations and troubleshooting of microbiological issues.Maintain accurate and timely records in compliance with regulatory requirements.Collaborate with cross-functional teams to support product development and quality control.Participate in internal audits and contribute to continuous improvement initiatives.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

An employer is seeking a Jr. Product Manager in the Cincinnati, OH area for a long term opportunity. This Jr. PM will be joining a leader in the medical device industry to support product/material... More discontinuation initiatives for multiple suppliers, international and external manufacturing sites as well as cross functional leaders across the engineering lifecycle. The day-to-day responsibilities will include program coordination and planning within Smartsheet for driving milestones, risks and decision points while tracking project timelines and burn down for the suppliers. They will also support supplier site coordination, discontinuation communication and coordinating sourcing, planning, quality, regulatory and operations check points while the company successfully moves towards other suppliers. Prior experience in a regulated environment would be ideal as well as strong organization and communication skills. This role will be on site three days a week and remote the other two.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

A client in the medical device space is seeking a Sr. Software Quality Assurance Engineer to join their organization for a 6-month contract to support internal projects. The ideal resource will be... More well versed in Quality SW principles within the medical device industry and have deep expertise in risk assessment, testing, design validation, and post market activities. This resource will support software quality efforts across the product lifecycle, contributing to design controls, risk activities, and post-market support. They will also help ensure IEC 62304 compliance, assist with testing, and support NCP, CAPA, and complaint processes alongside cross-functional teams. This role will be hybrid, onsite 3 days per week in Valencia, CA.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