Lead Regulatory Affairs Specialist Asia

**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 Danaher’s 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 Danaher Business System which makes everything possible.

The **Lead Regulatory Affairs Specialist Asia** is responsible for_ [insert a couple of sentences of the responsibilities for this job that drive significant impact to the organization]_.

This position reports to the Sr Manager, QARA Asia and is part of the **Medical Regulatory Affairs and Quality** located in Singapore_ _and will be an on-site role.

**What you will do**:
Essential responsibilities and not limited to:

- Strategize and manage all product registrations related activities to obtain timely approval from regulatory authorities in Asia. This includes new registration, renewals and change submissions. Liaise with regulatory authorities and drive collaboration with consultants/ distributors on submission requirements and input requests.
- Keep abreast of regulatory environment and evolving regulations; assess changes involving regulatory compliance and business impact.
- Post-market responsibilities (Adverse Events determination and reporting, FSCA/ Recall handling).
- Manage databases and documentations as part of Quality management requirements.
- Conduct internal quality audits and participate in internal and external quality audits.

**Who you are**:

- Bachelor’s Degree in Life Sciences, Engineering or other related fields with minimum 5 years of experience in the medical device industry within a regulatory affairs role
- Experience in regulatory submissions and interactions with regulatory authorities/ consultants/ distributors in different countries with in-depth knowledge of Asia regulatory requirements, standards, and guidelines
- Working knowledge of ISO 9001, ISO 13485, GDPMDS requirements
- Strong written and communication skills, meticulous and organized

**Travel, Motor Vehicle Record & Physical/Environment Requirements**:

- Ability for mínimal travel required at 10% or less in Asia and abroad

**It would be a plus if you also possess previous experience in**:
Global regulatory frameworks (EU MDD/MDR, US FDA)

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.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.