Senior Regulatory Affairs Specialist
2 months ago
DemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing submissions to regulatory bodies.
Responsibilities:
Prepare and submit regulatory documents required for the approval and registration of new and existing products in various markets.Stay informed on global regulatory requirements and changes, especially those related to medical devices and surgical sutures, and assess their impact on company products.Coordinate with R&D, quality assurance, and other departments to compile necessary documentation for regulatory submissions.Advise on regulatory requirements during product development stages.Monitor compliance with post-market surveillance and reporting obligations.Assist in developing and implementing regulatory strategies to support market entry and expansion.Provide regulatory support and guidance to internal teams and external partners.
Education:
Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
Communication skills:
Good technical capabilities, communication skills, teamwork abilities and initiative
Technical Proficiencies:
Regulatory Affairs Certification (US or EU) preferred. Proven ability to work well as part of a team & on own with minimum supervision. Working knowledge of FDA and other regulatory authorities with experience supporting compliance.
Experience:
6-8 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EU. A minimum of 6 years of experience in medical device, drugs, biologics, and/or combination products, preferred
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