Regulatory Affairs Specialist
Winston Salem, NC 27105
The working schedule is 8: 00am-5: 00pm at the Winston-Salem corporate office, and the pay rate is very competitive.
Responsibilities of the Regulatory Affairs Specialist will include the planning and preparation of submissions to obtain regulatory approvals for new and modified Class I, II, III and IV medical devices in specific markets. In addition to submissions, this position will serve as a communication liaison between the manufacturer and the Local Office/Distributor. The ideal candidate MUST have medical device experience, and experience in international submissions (preferably in APAC countries but will consider EU experience)
If you feel you meet this criteria and are pursuing new opportunities, we' d love to speak with you!
Responsibilities & Qualifications:
- Serve as a liaison on regulatory issues between the manufacturer and the local office and/or distributor
- Communicate region-specific (APAC countries) regulatory requirements to the Project team leaders and assist with the regulatory strategies
- Prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific regions
- Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability
- Previous Medical Device experience (no pharma or food), and MUST have experience in international submissions (preferably Korea or Japan but any international is okay)
- Proficient in reading, writing and speaking the English language
- Associates degree in Regulatory Affairs, Bachelor s degree in a related field is preferred
- Requires occasional early morning or late evening teleconferences
- Some travel may be required
Submit your resume online, or in person at 1292 S. Stratford Rd. Winston-Salem, to be considered for this position. For additional information, please call 336.970.5208 or text 336.970.5237.
While we appreciate all inquiries, only qualified candidates will be contacted for further information.