Job Summary
A leading medical technology company is filling a position for a Remote Staff Regulatory Affairs Specialist.
Must be able to:
- Assess regulatory intelligence
- Evaluate the regulatory environment and contributes to providing internal advice
- Anticipate regulatory obstacles and emerging issues
Qualifications for this position include:
- Bachelor’s Degree (B.S or B.A) in Engineering, Science or relevant focus
- Minimum of 5 years of Medical Device Regulatory Affairs experience
- General understanding of product development process and design control
- Previous experience drafting 510(k)s
- Experience interacting with regulatory agencies
- Excellent analytical and writing skills