Regulatory Affairs Professional Job At Radiometer
Radiometer, a Danaher operating company, is hiring a Regulatory Affairs Professional in Bengaluru East. This Regulatory Affairs Job role is ideal for experienced regulatory professionals in medical devices and IVDs who want to contribute to global healthcare innovation while working on EU MDR/IVDR, FDA, and global regulatory submissions across the product lifecycle. Graduates seeking B Pharma jobs or M Pharma jobs can apply now.
Job Details
- Job Title: Regulatory Affairs Professional
- Location: Bengaluru East, Karnataka, India
About the Company
Radiometer is a global leader in medical diagnostics and a part of Danaher’s operating companies. Focused on improving patient outcomes through fast, reliable diagnostics, Radiometer operates with a strong culture of innovation, continuous improvement, and global collaboration, powered by the Danaher Business System.
Educational Requirements
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Bachelor’s or Master’s degree in Pharmacy
Key Responsibilities
- Drive regulatory strategy across the product lifecycle, including development, maintenance, and post-market phases.
- Perform global regulatory change assessments for hardware, consumables, labeling, and process updates.
- Ensure compliance with EU MDR/IVDR, FDA, MDSAP, and country-specific regulations.
- Manage and maintain regulatory documentation including Annex II & III Technical Files, GSPRs, STED files, and 510(k) submissions.
- Support regulatory submissions and interactions with notified bodies, FDA, and global competent authorities.
- Monitor and interpret evolving global regulations and standards such as ISO 14971, IEC 62366, IEC 60601, and CLSI.
- Ensure audit and inspection readiness, including support for PMS, vigilance, non-conformances, and CAPA activities.
- Collaborate with cross-functional teams throughout the product lifecycle to ensure continued compliance.
Skills Required
- Strong knowledge of EU MDR/IVDR, FDA, MDSAP, and global medical device regulations.
- Experience with regulatory submissions, lifecycle management, and change assessments.
- Familiarity with ISO standards, risk management, usability engineering, and post-market surveillance.
- Excellent documentation, coordination, and stakeholder management skills.
- Ability to work in a fast-paced, globally connected regulatory environment.
Why This Job Role?
This Regulatory Affairs Job role offers exposure to global regulatory strategies for high-impact medical devices and diagnostics, collaboration with international stakeholders, and career growth within Danaher’s world-class regulatory ecosystem. Graduates seeking B Pharma jobs or M Pharma jobs can apply now.
