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Global Regulatory Affairs Specialist (REMOTE)

Company: The Resource
Location: Winston Salem
Posted on: November 22, 2021

Job Description:


The Resource is hiring a Global Regulatory Affairs Specialist for our client, a medical device manufacturer, located in Winston-Salem. This is permanent, Direct-Hire opportunity and offers a competitive salary and benefits package. This position is 100% fully remote. The primary purpose of this position is to create and maintain international regulatory registrations for medical devices supporting the GI Endoscopy and Gastroenterology fields. Qualified candidates should have relevant work experience in this field. Regulatory experience in Japan, Korea, China, etc. is preferred for this role. If you' re seeking an opportunity to take your career to the next level with a new opportunity, Apply Today! Responsibilities: - Plan and prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific country/region - Interface directly with regulatory authorities, both international and local offices - Maintain re-registration approvals in advance of license expirations to ensure no disruption in product availability - Must work and interact effectively and professionally with and for others throughout various levels of the global organization - Review, approve or modify advertising, product labels and instructions for use for compliance with domestic and international regulations Qualifications: - 4 year degree in applicable field or equivalent experience. - Minimum 2 years experience in medical device field - Regulatory experience with East Asian markets (e.g., Japan, Korea, China) preferred - Position is100% fully remote Submit your resume online, or send directly to Julia Yeargan at to be considered for this position. For more information, please call our office at . While we appreciate all inquiries, only qualified candidates will be contacted for further information.

Keywords: The Resource, Winston-Salem , Global Regulatory Affairs Specialist (REMOTE), Other , Winston Salem, North Carolina

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