Regulatory Affairs Specialist

Regulatory Affairs Specialist – Medical Device Industry Position Summary The Regulatory Affairs Specialist is responsible for supporting regulatory activities to ensure medical devices comply with applicable global regulatory requirements and standards. This role collaborates with cross-functional teams, including Research & Development, Quality Assurance, Clinical Affairs, Manufacturing, and Marketing, to support product development, registrations, submissions, and post-market regulatory compliance. Key Responsibilities Prepare, review, and maintain regulatory submissions and registrations for medical devices in domestic and international markets. Support the development and execution of regulatory strategies for new product introductions, product modifications, and market expansion activities. Ensure compliance with applicable regulations, standards, and guidance documents, including FDA, EU MDR, ISO 13485, and other global requirements as applicable. Compile and maintain technical documentation, regulatory files, declarations, labeling, and product registrations. Review product labeling, promotional materials, and marketing claims for regulatory compliance. Monitor and interpret changes in global regulatory requirements and communicate potential impacts to internal stakeholders. Participate in cross-functional product development teams to provide regulatory guidance throughout the product lifecycle. Support regulatory assessments related to design changes, manufacturing changes, and supplier modifications. Assist with regulatory inspections, audits, and responses to regulatory agency inquiries. Collaborate with Quality Assurance on compliance activities, corrective and preventive actions (CAPA), risk management, and post-market surveillance requirements. Maintain regulatory databases, submission tracking systems, and product registration records. Support international distributor and business partner regulatory requirements as needed. Qualifications Education Bachelor's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Chemistry, Biology, Engineering, or a related scientific discipline. Advanced degree or Regulatory Affairs Certification (RAC) preferred. Experience Typically 2–5 years of experience in regulatory affairs within the medical device, diagnostics, or healthcare industry. Experience preparing regulatory submissions and maintaining regulatory documentation. Knowledge of medical device regulations and quality system requirements. Knowledge, Skills, and Abilities Understanding of FDA regulations, including 21 CFR Parts 803, 806, 807, 812, and 820. Familiarity with EU MDR 2017/745 and international regulatory frameworks. Knowledge of ISO 13485, ISO 14971, and medical device quality systems. Strong technical writing, document management, and communication skills. Ability to interpret regulations and apply them to business and product development activities. Excellent organizational skills with attention to detail. Ability to manage multiple projects and meet deadlines in a fast-paced environment. Proficiency with Microsoft Office applications and regulatory document management systems. Preferred Qualifications Experience with Class II, or III medical devices. Experience supporting 510(k), De Novo, PMA, CE Marking, or international regulatory submissions. Knowledge of post-market surveillance, vigilance reporting, and change control processes. Experience working in a regulated quality management system environment. Working Conditions Office or hybrid work environment. Occasional travel may be required for audits, inspections, training, or regulatory meetings. Ability to work effectively with cross-functional and global teams. Success Factors Demonstrates strong regulatory judgment and attention to compliance. Maintains accuracy and quality in regulatory documentation. Proactively identifies regulatory risks and recommends practical solutions. Stays informed of evolving regulatory requirements and industry best practices. #J-18808-Ljbffr