Regulatory Device Specialist

📋 Description

• Prepare and submit regulatory submissions to FDA and international authorities within timelines.
• Support preparation, review, and archival of electronic and paper regulatory submissions.
• Act as SME on domestic and foreign medical device regulations.
• Coordinate regulatory reviews for post-market changes and change control decisions.
• Assist in updating internal policies and procedures.

🎯 Requirements

• Minimum 3 years Medical Device Regulatory experience.
• Solid understanding of cGMP for medical devices, ISO 13485, FDA and EU MDR requirements.
• Experience obtaining/maintaining registrations in multiple markets outside the US
• Authoring/compiling regulatory dossiers (FDA 510(k), EU MDR Technical Documentation, IMDRF/STED
• Knowledge of MDSAP, UKCA, Notified Body processes, country labeling/UDI requirements.

🎁 Benefits

• Competitive compensation and annual bonus eligibility.
• Comprehensive healthcare benefits and retirement plan options.
• Generous PTO, holidays, and parental leave.