Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Radiometer, one of Danaher’s (https://danaher.com/our-businesses) 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.
At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We’re a team that celebrates diverse ideas and continuous improvement. Here, you’ll find a place to grow and make a real impact, with your unique perspective driving us forward in improving patient care. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Regulatory Affairs Specialist at Radiometer is responsible for coordinating regulatory activities and providing regulatory input related to products including blood gas analyzers, immunoassay analyzers, blood gas syringes, and capillary tubes by collaborating with cross-functional project teams throughout the development lifecycle and maintenance phase to ensure continued global compliance
This position reports to the Principal Specialist, Regulatory Affairs and is part of the regulatory affairs department located in north bengaluru, India and will be an on-site role. If you thrive in a fast-paced environment, is used to playing a critical supporting and coordinating role and want to work to build a world-class efficient team that is part of a Global RA department and have interactions and stakeholders to connect with in a global scale—read on.
In this role, you will have the opportunity to:
+ Drive regulatory strategy and provide guidance throughout the product system lifecycle (including hardware, software, consumables and accessories) in collaboration with a cross functional project team.
+ Perform regulatory change assessments for product (hardware, software, consumables and accessories), process, labeling updates across global markets (including but not limited to EU, US, China, other MDSAP countries) ensuring timely, compliant implementation in alignment with FDA, EU MDR/IVDR, MDSAP requirements and country-specific requirements.
+ Manage, review and maintain regulatory documentation and submissions, including EU MDR/IVDR technical documentation (Annex II & III), GSPRs, STED files, 510(k)s, and other global registration driven by lifecycle changes.
+ Monitor and interpret evolving global regulations and standards (e.g., ISO 14971, IEC 62366, IEC 60601, IEC 62304, CLSI) and proactively share insights and guidance with cross-functional teams to ensure continued compliance.
+ Ensure audit and inspection readiness by maintaining robust documentation and supporting product lifecycle management compliance activities such as PMS, vigilance, review of marketing material, NCs and CAPAs.
The essential requirements of the job include:
+ Bachelor’s or master’s degree in science, engineering, pharmacy, biology, biotechnology, medical technology, or related field.
+ Over 7 years of experience in the regulated medical device industry for candidates with a master’s degree, or 9 years for those with a bachelor’s degree including work with medical devices or in-vitro diagnostics regulations, guidelines and standards.
+ Skilled in performing global regulatory change assessments to ensure compliance with EU MDR/IVDR, FDA, MDSAP, and country-specific regulations.
+ Proven ability to lead regulatory strategies across the product lifecycle, including design control, risk assessments, change assessments, and product launches.
+ Experienced in maintaining regulatory documentation and managing submissions, including STED files, 510(k)s, global registrations, and communications with notified bodies, FDA and other country-specific competent authorities.
Travel, Motor Vehicle Record & Physical/Environment Requirements: i
+ Ability to travel – some travels to other Radiometer sites incl HQ in Copenhagen, Denmark.
It would be a plus if you also possess previous experience in:
+ Global regulatory experience, including registrations beyond EU and US (e.g., China NMPA, Brazil ANVISA, Japan PMDA), demonstrating ability to navigate diverse regulatory landscapes with proven success in submissions and authority interactions. (e.g., audits, deficiency responses).
+ Strong technical and SME expertise in ISO 14971, IEC 62366, IEC 62304, EMC, CLSI, FDA guidance for IVD’s, and broad domains including software, analytical chemistry, usability, stability, UDI, clinical, and post-market surveillance.
+ Provide strategic regulatory guidance across cross-functional teams to resolve complex regulatory issues, ensuring compliance with global regulations and facilitating successful governmental approvals through expert interpretation and planning.
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 .
