Senior Regulatory Affairs Specialist

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology

At Cytiva, one of 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.

Learn about the which makes everything possible.

The Senior Regulatory Affairs Specialist is responsible for managing medical device regulatory activities in India to ensure timely market access, ongoing regulatory compliance, and uninterrupted product supply. Serving as the primary regulatory contact for India, this role manages regulatory submissions, product lifecycle changes, post-market obligations, and regulatory intelligence. The position works closely with internal stakeholders and external regulatory authorities to proactively mitigate regulatory risk and also supports regulatory activities across ASEAN markets.

This position reports to the Sr Manager, Regulatory Affairs & Quality Asia and is part of the Medical Regulatory Affairs & Quality located in Singapore and will be fully remote. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

What you will do:

Essential responsibilities and not limited to:

• Manage India regulatory activities for medical devices, including registrations, renewals, variations, labelling compliance and lifecycle management in compliance with India Medical Device Rules (MDR) 2017 and other applicable regulations and requirements. Compile and submit registration documents, liaise with regulatory authorities and consultants to ensure timely approvals.
• Assess regulatory impact of post-approval changes including design changes, labeling changes, warehouse changes, supplier or manufacturing site changes.
• Support postmarket regulatory activities, including Adverse Event reporting, Field Safety Corrective Action (FSCA)/Recall.
• Monitor and communicate regulatory intelligence and assess impact maintain regulatory documentation and databases, utilize Regulatory Information Management Systems (Veeva RIM)
• Support assigned regulatory activities across ASEAN markets to enable compliance and business objectives.

Who you are:

• Bachelor's Degree/ Diploma in Life Sciences, Engineering or other related discipline with minimum 3 years of RA experience within medical device industry
• Experience with India CDSCO submissions for medical devices and interactions with regulatory authorities and consultants.
• Good knowledge of India MDR & ASEAN regulatory frameworks
• Working knowledge of ISO 13485 requirements
• Strong written and communication skills, meticulous and organized

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability for minimal travel required at 10% or less within India and abroad

It would be a plus if you also possess previous experience in:

• Global regulatory frameworks (EU MDD/MDR, US FDA)

Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at .

At Cytivawe believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytivacan provide.

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

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