What are the responsibilities and job description for the Regulatory Affairs Specialist position at Lumicity?
Senior Regulatory Affairs Specialist
My client is seeking a Senior Regulatory Affairs Specialist to help simplify diabetes management through insulin pump technology. The goal is to empower people to manage their diabetes with ease, without needing to be experts in tech or math.
Compensation : Competitive hourly rate with potential for contract extension.
Key Responsibilities :
- Provide regulatory guidance and feedback to project teams
- Develop regulatory strategies for new devices and post-market changes
- Prepare filings for new products and major changes
- Identify and communicate risks in regulatory strategies
- Lead and negotiate regulatory meetings with government agencies (e.g., FDA, Notified Bodies)
- Lead the preparation of regulatory filings (PMAs, 510(k)s, EU Technical Documentation)
- Ensure compliance with US regulations, ISO 13485, MDD / MDR, CMDR, and others
- Assist in training junior staff
- Other duties as needed
Education & Experience :
Required Skills :
Benefits May Vary
Preferred Skills :
Note : Only local applicants with the legal right to work in the US will be considered.
Interested? Contact Reese Owens on LinkedIn or at 202-967-3339. You can also email your resume to reese.owens@lumicity.io.
