Lead Regulatory Affairs Specialist

Summary This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance This position participates on cross-functional teams leads the development of global regulatory strategies authors regulatory submissions interacts with regulatory agencies notified bodies reviews design control documents and product labeling and evaluates proposed device changes This position interprets and communicates regulatory issues to ensure the business is aware of opportunities risks and concerns and provides recommendations to minimize risk P3-14314 - TCI Role - JG 3C Job Responsibilities Represents Regulatory Affairs on product development teams to support change control to ensure US EU and other global regulatory requirements are met Evaluates medical device regulations and leads development of global regulatory strategies to bring products to market Reviews and approves design control documentation and product labeling in consideration of US EU and other global regulatory requirements Authors FDA submissions EU technical files and other regulatory documents for submission to regulatory bodies for product review and approval Point of contact for FDA EU notified bodies and other regulatory agencies on submissions and other issues Independently reviews product changes to ensure regulatory compliance including assessment of impact to US and CE Mark and prepares resulting notifications Communicates changes to global regions and supports preparation of global notifications as needed Understands fundamental global regulatory requirements and different regulatory pathways Stays informed of new regulations and changes to existing regulations and communicates to project teams Maintains regulatory databases and systems Supports regulatory body audits CAPAS and other compliance activities Reviews advertising and promotional material Participates and leads training related to areas of expertise Mentor other regulatory colleagues Education and Experience Bachelor s degree or higher preferably in a scientific discipline Master s degree in Regulatory Affairs preferred Regulatory Affairs Professional Society RAPS certification preferred 7- 12 years Regulatory Affairs experience in the medical device industry Experience working with FDA EU notified bodies and other regulatory agencies Experience with US 510 k CE mark EU MDD MDR and other international requirements and submissions Proven experience owning and managing the end-to-end process of authoring submitting and obtaining regulatory approvals clearances 510 k s including addressing and responding to deficiencies from regulatory agencies Experience with product development processes and design controls Knowledge and Skills Excellent written and verbal communication skills Excellent problem solving and analytical skills Detail-oriented with a focus on accuracy and completeness Excellent organization skills able to manage multiple tasks and meet timeline commitments Ability to work in a team-oriented fast-paced environment Demonstrated ability to analyze interpret review and summarize scientific technical and regulatory information Comprehensive understanding of global medical device regulations with in-depth knowledge of US and EU requirements Knowledge of product development and medical device quality system regulations Ability to mentor and teach other regulatory associates Proficient in use of Microsoft Office tools including Word Excel PowerPoint Required Skills Optional Skills Primary Work Location IND Bengaluru - Technology Campus Additional Locations Work Shift