Apr 21, 2019
We' re seeking a Regulatory Affairs Specialist for our medical device manufacturing client in Winston-Salem! This is a long-term contract opportunity that will last approximately 6+ months, but potentially longer. The working schedule is 8: 00am-5: 00pm, with a very competitive pay rate. 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 Korea or Japan). 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 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.
The Resource Winston-Salem, NC, USA