Senior Specialist, Commercial Quality & Regulatory Affairs

Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?  
Within Danaher the work our diagnostic businesses do 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. 
We’re accelerating the development of cutting-edge diagnostics to solve some of the world’s most pressing health challenges. Across our diagnostics operating companies, we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. We’re bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we’re expanding access to precision diagnostics for millions of people worldwide - and we’re using our unmatched global scale and proven playbook to make it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we’re improving treatment options and saving lives.
Learn about the Danaher Business System which makes everything possible.

The Specialist, Commercial Quality & Regulatory Affairs will prepare regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals. This individual will represent RA on project core teams, coordinate and prepare document packages for regulatory submissions from all areas of company as well as for internal audits and inspections.  Compile all materials required in submissions, license renewal, and annual registrations.  Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.  Keep abreast of changes of new or updated regulatory policies and issued guidance.

This position reports to the Senior Manager, Commercial Quality & Regulatory Affairs and is part of the Center of Excellence located in Singapore and will be fully remote.  

In this role, you will have the opportunity to:

• Lead pre-market and post-market regulatory activities for IVD devices, including preparation and submission of technical documentation, regulatory applications, change notifications, renewals, and responses to regulatory bodies and partners. 
• Maintain and manage regulatory intelligence and compliance at local, regional, and global levels, ensuring adherence to applicable regulations throughout the product lifecycle. 
• Oversee quality management processes and continuous improvement, including compliance operations, audits, CAPA, distributor and warehouse oversight, and acting as Quality Management Representative (QMR) when required.

The essential requirements of the job include :

• Bachelor’s degree with 6+ years of relevant experience or a certificate in medical devices with 3 years of experience or 4+ years of experience in the medical devices or a related industry.
• Understands Regulatory Affairs concepts and is should be familiar with regulations/ guidelines governing development of diagnostic products
• Ability to prioritize, multitask, and organize work, succeed in a fast-paced environment with capability to be flexible and adaptable to meet business needs

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel – 10%

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

• Certified audit certificate for ISO13485 or ISO9001 or GMP 
• Support local audits
• Ability to perform in country IVD/MD submission with authority in Southeast Asia country

Within Danaher Diagnostics, we offer 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.

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.

For more information, visit www.danaher.com.