Job Description

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:

• Bachelor’s degree in Science, Engineering, or related field
• 4+ years in Regulatory Affairs in medical devices or similar regulated industries

Required Skills:

• Strong communication skills (written & verbal)
• Experience with FDA, ISO, EU regulations for medical devices
• Familiarity with regulatory requirements for complaint handling, reporting, and CAPA
• Project management, organizational, and analytical skills

Benefits May Vary

Preferred Skills:

• Knowledge of medical device processes (e.g., reliability, software, biocompatibility)

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.

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