Regulatory Affairs Specialist

Role: Regulatory Affairs Associate Location: Alameda, CA Key Responsibilities and Requirements: Regulatory Review & Compliance: The primary responsibility is to review and assess regulations from various countries, identifying their impact on business compliance. Regulatory Impact Awareness: Candidates must understand the consequences of failing to meet regulatory compliance deadlines. High Proficiency in Regulatory Understanding: The role requires strong expertise in interpreting and applying regulatory standards. Document Review & Approval: Will review, assess, and approve regulatory documents, addressing any compliance gaps as necessary. Cross-functional Collaboration: Work closely with teams across R&D, Quality, Manufacturing, Bio Compatibility, and Supply Chain to evaluate the regulatory impact on different departments. Quality System Documentation: Use the Quality System to document regulatory reviews and ensure compliance processes are properly recorded. Experience & Skills Required: Regulatory Experience: 2-4+ years of experience reviewing and assessing regulations is essential. Relevant Knowledge Areas: Familiarity with EUMDR, CFR 820.30, Medical Device Design Controls, and combination devices is required. Industry Experience: Experience in medical devices or in vitro diagnostic (IVD) products. Educational Background: Bachelor's degree in Computer Science, Mechanical Engineering, Biomedical Engineering, or Electronics preferred.