Job Openings
Regulatory Affairs Specialist - Post Market
About the job Regulatory Affairs Specialist - Post Market
Job Title: Regulatory Affairs Specialist - Post Market
Job Location: United States
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
- Remote position, west coast hours mandatory
- Coordinate the complaint handling process to include processing of reportable events
- Provide information as requested for the filing of FDA recalls
- Coordinate FMI process, including monitoring and reporting status and completion
- Process electronic submissions (e.g. 3500A, 2579, Product Reports, Annual Reports)
- Coordinate state registrations, including monitoring regulations and preparing and submitting documentation to each state as required
- As requested, write/review CMSU policies, procedures and guidance documents incorporating regulatory requirements/actions
- Assist in maintaining proper preparedness for State or Federal (FDA) authorities
- Represent interests of RA in cross functional teams as needed
- Excellent interpersonal, communication, and organizational skills
- Ability to develop and maintain effective working relationships internally and externally
- Good PC skills, including MS Word, Excel, Oracle, Sales Force, etc.
- 2 Years Regulatory Affairs experience in medical device industry required
- Minimum Education Level: 2 Year / Associate's Degree
- 4 Year/ Bachelor's Degree (STEM) preferred
- Pay Information: Min. salary of $72,000 to max $116,100 (annual equivalency)
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