Regulatory Affairs Consultant

hace 2 semanas

Lima Metropolitana, Perú BioTalent A tiempo completo

We are seeking an experienced Medical Device Regulatory Consultant to support regulatory strategy, submissions, and compliance activities for Class II and/or Class III devices. This role will collaborate closely with cross-functional teams, ensuring products meet FDA and international regulatory requirements from development through commercialization. Responsibilities Develop, review, and execute regulatory strategies for new and existing medical devices, including US FDA, EU MDR/IVDR, and other international markets. Prepare, compile, and submit regulatory submissions (e.g., 510(k), PMA supplements, IDEs, Technical Documentation, Design Dossiers). Advise on regulatory requirements for product development, manufacturing changes, labeling, marketing claims, and clinical activities. Assess the regulatory impact of design changes, manufacturing modifications, and process improvements. Monitor and interpret changes in global regulations and standards, providing guidance to internal teams. Support and lead interactions with regulatory agencies, including FDA, Notified Bodies, and other authorities. Ensure all documentation is accurate, complete, and compliant with applicable regulations. Train and mentor internal teams on regulatory processes and best practices. Qualifications Bachelor’s degree in a scientific or engineering discipline (advanced degree preferred). Minimum 7+ years of regulatory affairs experience in the medical device industry. Proven track record with successful US and international submissions for Class II/III devices. Strong working knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and MDR/IVDR requirements. Experience with combination products, software as a medical device (SaMD), or IVDs a plus. Excellent organizational, communication, and problem-solving skills. Ability to work independently and manage multiple priorities in a fast-paced environment. Details Seniority level: Mid-Senior level Employment type: Contract Job function: Regulatory Affairs Industries: Medical Equipment Manufacturing Location: San Diego, CA. Salary: $145,000.00–$165,000.00 per year. #J-18808-Ljbffr

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