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About the role
Key responsibilities & impact- Monitor and ensure the timely preparation and tracking of technical documentation related to design changes, in coordination with the relevant teams.
- Assist in documentation preparation and publishing for regulatory submissions.
- Assist in implementing an automated system for the regulatory and standards watch process.
- Proactively monitor and ensure timely renewal of licenses, including Small Business Determination, Device Listing, and Establishment License for the US market.
- Facilitate promotional marketing review by setting up a centralized database of validated marketing and clinical claims.
- Perform regulatory watch to ensure compliance with FDA regulations, ISO standards, and other relevant regulatory requirements, and provide support for regulatory impact analyses.
- Provide support for post-market compliance activities.
Requirements
What you’ll need- Currently pursuing a Bac+5 (Master’s-level) degree in a medical devices-related field preferred (engineering degree, Master's in Regulatory Affairs, etc.).
- Knowledge of medical devices; experience with software medical devices is a plus.
- Experience in quality and regulatory affairs is a plus.
- Fluent in French and English.
- Strong team player; this role will interact with most internal teams.
Benefits
Comp & perks- N/A 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
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Hard Skills & Tools
regulatory submissionstechnical documentationautomated systemsregulatory complianceregulatory impact analysespost-market compliancequality affairsmedical devicessoftware medical devices
Soft Skills
team playercommunicationproactive monitoring
Certifications
Bac+5Master's in Regulatory Affairs