Senior Regulatory Affairs Specialist
Job Summary
To support groundbreaking technology development, the full-time Senior Regulatory Affairs Specialist will prepare and manage global regulatory submissions while collaborating with cross-functional teams in a remote setting, preferably from the East Coast.
Key responsibilities
- Prepare and manage global regulatory submissions, including EU MDR and FDA IDE/PMA
- Advise on regulatory strategies for product development and compliance
- Lead process improvement initiatives to enhance regulatory efficiency
Required qualifications
- Bachelor's degree in Science, Pharmacology, or a related field
- 5+ years of regulatory experience in medical devices or pharmaceuticals
- Strong experience with PMA authorship and submissions
- Proven success with Class III device submissions and CE Marking
- Fluency in English
Complete Job Description
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