Regulatory Affairs Specialist

Job description

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745).         Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers.         Global regulatory experience or knowledge is added advantage.         Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle.         Assess the regulatory impact of product and process changes and ensure proper documentation and notification.         Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings.         Review and approve product labeling, IFUs, and promotional materials for compliance with US and EU regulations.         Ensure compliance with Unique Device Identification (UDI) requirements and support EUDAMED submissions.         Provide regulatory oversight for post-market surveillance, vigilance reporting, and adverse event investigations.         Liaise with regulatory authorities including FDA and Notified Bodies, managing communications and submissions.         Mentor junior regulatory team members and provide training on evolving regulatory requirements and best practices.         08+ years of experience, specifically focused on Medical Devices in the US and EU markets Roles and Responsibilities Under general supervision, performs the design, layout, testing, and evaluation of mechanical and electro-mechanical devices or systems. Performs product development activities including drawing board layout and interpretation and implementation of customer specifications and documentation requirements. Provides existing product line support in design activities and/or modification of hardware in production. Conducts engineering studies and may assign work to technical drafting staff. At this level, assignments are moderately complex and require use of initiative and judgment.