Sr. Regulatory Affairs Specialist

Job Description

We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team and play a key role in ensuring the regulatory compliance of our engineering services projects for leading global Healthcare/ MedTech clients. You will work closely with our engineering and quality teams, as well as clients regulatory team, to navigate the regulatory landscape and ensure a smooth and successful product launch. Roles & Responsibilities : Collaborate with clients regulatory team to understand their specific regulatory requirements and strategies for its MedTech products. Provide regulatory guidance and support to our engineering and testing teams, ensuring that the system design, development, and testing activities comply with relevant regulations and standards (IEC 62304, FDA guidelines, ISO 13485, etc. ). Assist in the preparation and submission of regulatory documentation, including 510(k) premarket notifications or PMA applications (as applicable), ensuring completeness, accuracy, and adherence to regulatory guidelines. Monitor and track regulatory changes and updates, keeping the team informed of any relevant developments and advising on necessary adjustments to the project plan or system design. Conduct regulatory research and analysis, providing insights and recommendations on regulatory strategies and compliance requirements. Maintain up-to-date knowledge of relevant regulations, standards, and guidance documents related to medical devices. Support internal audits and regulatory inspections, ensuring that all documentation and processes are compliant. Collaborate with cross-functional teams (engineering, quality, marketing) to ensure that regulatory requirements are considered throughout the product lifecycle.