Regulatory Affairs Specialist (Submissions)
Winston Salem, NC 27105
Responsibilities & Qualifications:
- Serve as a liaison on regulatory issues between the manufacturer and the local office and/or distributor
- Communicate region-specific 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
- Collaborate with Regulatory Scientific Affairs on all high risk devices and new technologies
- Collaborate with the Clinical Functional Unit on projects requiring the collection of clinical data
- Provide support to currently marketed products as necessary including input on change requests, etc.
- Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations
- 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
- Comfortable working in a general office environment, and sitting for extended periods
- Requires occasional early morning or late evening teleconferences
- International and domestic travel as 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.