Regulatory Specialist

2 weeks ago

bangalore, India Novo Nordisk Full time

The position

As a RA Specialist, the ideal candidate will be responsible to design RA Strategy from late stage development and throughout Life cycle of the device project, prepare and submit high quality files to the authorities achieving fast approvals. Act as an ambassador for assigned medical devices/device part of combination products. This role involves planning, coordinating and executing the regulatory tasks as required for existing device products in accordance with the Global Regulatory Device Strategy for the defined area of responsibility in collaboration with manager and colleagues. RA Specialist will be an SME for the defined area of responsibility. Mentor and provide technical sparring to project team on device regulatory pathways Key tasks and responsibilities will be: Regulatory Strategy Development: Develop and implement regulatory strategies for Drug-Device Combination products in alignment with current legislation, ensuring compliance with regulatory requirements and standards. Documentation Management: Compile, review, and submit Technical Documentation and submission packages, while ensuring the appropriateness of scientific/technical documentation for specific regulatory purposes. Stakeholder Support: Provide effective support and advice to stakeholders to minimize time to market, facilitating timely product approvals and launches. Engagement with Health Authorities: Maintain dialogue, negotiate, and represent Novo Nordisk in interactions with relevant health authorities and notified bodies, ensuring compliance and fostering positive relationships. Project Management and Coordination: Plan, coordinate, and project manage regulatory activities, including handling Change Requests, corrective and preventive actions (CAPA) cases, and representing Regulatory Affairs in audits and core groups for device development, production, and launch coordination. Qualifications A Graduate or Post Graduate Degree in Pharma, Biomedical and Engineering graduates preferred. Experience in handling regulatory submissions of medical devices or drug device combination products across the globe. Depending on the qualification, ideally more than 10 years experience in handling RA activities of Combination products, connected Medical Devices either from the pharmaceutical industry, medical device industry, notified bodies or from a medical agency Experience in handling regulatory submissions and post market changes of medical devices, Drug-Device Combination products globally. Knowledge on MDR and Current Standards is mandatory. A scientific and technical mindset with familiarity on matrix organisation set-up. Experience in project management and experienced with process management in highly regulated environment. Ability to communicate on complex topics scientifically and professionally to different stakeholders across the organisation. Strong communication skills and fluency in written and spoken English. Ability to cross collaborate and work with the teams and stakeholders from different backgrounds and culture in a Hybrid setup. Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a -year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63, employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us Together, we go further. Together, we’re life changing.

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