Regulatory Affairs Specialist
$79,000–$119,000 year
Remote
Job Summary
Plan and execute global regulatory activities to obtain and maintain approvals for new devices, launch markets, and post-market changes. Prepare comprehensive regulatory strategies and determine requirements for product submissions and filings. Communicate regulatory requirements to internal and external customers, recommend pathways, and review documentation to ensure compliance. Collaborate with internal and external groups to complete filings, evaluate technical information, and support responses to regulator questions. Participate in labeling development and act as a subject matter expert to solve complex issues. Requires a life science degree, two years of regulatory experience, and up to 5% travel. Salary $79,000–$119,000 annual.
Required Qualifications
- B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related
- 2 years of experience in medical device regulatory affairs or quality assurance
- Understanding of the current Regulatory environment and demonstrating the ability to perform within
- Applied knowledge of FDA regulations and guidelines
- Ability to evaluate information to determine compliance with standards, laws, and regulations
- Travel required up to 5%
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