eGRC Business Analysis Specialist – Laws, Rules and Regulations
TD
Regulatory Affairs Specialist
Spectrum Vascular
full-time
Posted on:
Location Type: Hybrid
Location: Bridgewater • New Jersey • 🇺🇸 United States
Visit company websiteJob Level
Junior
About the role
- Assist in the preparation, formatting, and compilation of regulatory submissions (e.g., FDA 510(k), EU MDR Technical Documentation)
- Support the maintenance of regulatory files, declarations of conformity, and device listings/registrations
- Support responses to regulatory agency requests for additional information
- Support U.S. and EU market approval processes and ensure compliance with regulatory standards
- Support post-market submissions (progress reports, annual reports, etc.)
- Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers
- Collaborate with Quality Assurance to ensure continued compliance with applicable regulatory standards
- Participate in internal audits, management reviews, and external audit preparations as needed
Requirements
- Bachelor’s degree in a scientific area (RAC certification preferred)
- 1-3 years of experience in a regulated FDA environment (medical devices or combination products)
- Hands-on experience with 510(k) submissions (IDE and PMA knowledge a plus)
- Strong understanding of FDA and EU medical device regulations (international experience desirable)
- Strong organizational, communication, and planning skills
- Proficiency with PC systems and office applications
- Solid understanding of scientific principles applied to regulatory affairs
Benefits
- Health insurance
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsFDA 510(k)EU MDR Technical Documentationregulatory assessmentspost-market submissionsIDE knowledgePMA knowledgescientific principles applied to regulatory affairs
Soft skills
organizational skillscommunication skillsplanning skills
Certifications
Bachelor’s degree in a scientific areaRAC certification
