Regulatory Manager

Lead Engineering, Regulatory, Quality and Clinical Affairs Recruiter, Medical Device & Diagnostics at BioTalent and Investigo, part of The IN Group Position Summary: We are actively searching for an experienced and strategic Regulatory Affairs Manager to join our team. This pivotal role will be responsible for overseeing global regulatory submissions and ensuring compliance for our diverse medical device portfolio. You will be instrumental in developing and executing regulatory strategies for both new product introductions and product lifecycle management, ensuring strict adherence to requirements set by the US FDA and European regulatory authorities. Key Responsibilities Develop and execute comprehensive regulatory strategies for new product development and sustaining engineering initiatives. Prepare, submit, and diligently manage regulatory applications, including submissions to the US FDA (e.g., 510(k), PMA) and EU Notified Bodies (e.g., Technical Files, Design Dossiers). Act as the primary contact with regulatory agencies, addressing submission deficiencies and responding promptly to requests for additional information. Represent Regulatory Affairs on various cross-functional product development teams, offering expert guidance on regulatory requirements, compliance, and risk mitigation. Maintain continuous regulatory compliance throughout the entire product lifecycle, managing change assessments and post-market surveillance activities. Collaborate effectively with internal departments (R&D, Quality, Clinical, Manufacturing, Marketing) and external consultants to ensure all regulatory requirements are seamlessly integrated into product development and documentation processes. Proactively monitor and interpret evolving global regulatory requirements, communicating the impact and necessary actions to internal stakeholders. Provide crucial support during audits and inspections conducted by regulatory authorities and notified bodies. Contribute to regulatory intelligence gathering and strategy formulation to facilitate global market access. Preferred Qualifications Bachelor’s degree in a scientific, engineering, or a related technical discipline (an advanced degree is preferred). 7–10 years of progressive Regulatory Affairs experience within the medical device industry. A proven record of successful submissions to, and experience interacting with, the US FDA and EU Notified Bodies. Prior experience supporting both new product development and sustaining/post-market activities. Strong, in-depth understanding of global medical device regulations (e.g., FDA CFR, EU MDR/IVDR). Experience with CMC (Chemistry, Manufacturing, and Controls) is beneficial but not mandatory. Demonstrated leadership ability in managing regulatory projects or small teams. Exceptional communication, project management, and analytical problem‑solving skills. RAC (Regulatory Affairs Certification) or equivalent professional certification is a plus. Seniority level Mid‑Senior level Employment type Full‑time Job function Engineering, Legal, and Quality Assurance Industries Medical Equipment Manufacturing and Hospitals and Health Care #J-18808-Ljbffr BioTalent