Job Description
Our client is seeking a contracted Regulatory Specialist to support the Vice President of Quality Assurance and Regulatory Affairs. The contractor will focus on the execution of regulatory documentation, submissions, and compliance tasks to ensure timely delivery of project milestones. This position is ideal for a detail-oriented regulatory professional with hands-on experience in EU MDR and working knowledge of FDA, Health Canada, and Japan PMDA requirements.
Scope of Work
- Draft, review, and maintain regulatory submissions and technical documentation for EU MDR, FDA, Health Canada, and Japan PMDA.
- Ensure all documentation aligns with Resoundant’s Quality Management System (ISO 13485, ISO 14971) and applicable international standards.
- Prepare inspection-ready files and assist with regulatory audits under the direction of the VP of Quality/Regulatory.
- Track project deliverables, regulatory timelines, and status reports for leadership.
- Collaborate with Quality, Regulatory, Clinical, and Engineering teams on project-specific regulatory needs.
- Monitor evolving regulations (EU MDR, Health Canada MDSAP, Japan PMDA) and summarize implications for leadership review.
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/.
Required Skills & Experience
- Bachelor’s degree in science, engineering, regulatory affairs, or related field.
- 3–5 years of regulatory experience in the medical device industry, with proven EU MDR expertise.
- Familiarity with FDA 21 CFR Part 820, Health Canada, and Japan PMDA requirements.
- Strong technical writing, documentation, and project coordination skills.
- Experience working within ISO 13485 and ISO 14971 frameworks.
Nice to Have Skills & Experience
- Experience preparing Technical Documentation under EU MDR, Health Canada, and Japan PMDA.
- Familiarity with MDSAP audits.
- RAC certification (EU/US/Global) or progress toward certification.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.