A company is looking for a Regulatory Affairs Specialist to support US and OUS regulatory activities for Class II and III products.
Key Responsibilities : Participate in product development teams to provide regulatory supportCompile technical documentation for global regulatory submissions and registrationsReview QMS and product changes for compliance with regulatory requirementsRequired Qualifications : Bachelor's Degree in STEM, Medicine, or Life Science1-2 years of experience in medical device product development or related fieldsFamiliarity with medical device regulations in the US and / or EUKnowledge of relevant standards and guidance documents (e.
g., 21 CFR 820, MDR)Experience in regulatory affairs, clinical affairs, Quality, or Engineering is required
Regulatory Affairs Specialist
A company is looking for a Regulatory Affairs Specialist to support US and OUS regulatory activities for Class II and III products. CFR 820, MDR)Experience in regulatory affairs, clinical affairs, Quality, or Engineering is required. ...
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Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. ...
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The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Position: Sr Regulatory Affairs SpecialistLocation: Sunnyvale, CaliforniaPosition...
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