Philips, a global leader in health technology, is expanding its Regulatory Affairs team in Pune, India. The company is hiring Regulatory Affairs Specialist and Regulatory Affairs Operations Specialist to manage international filings, compliance, and licensing for MedTech products. These roles offer excellent growth opportunities for professionals with 3–5+ years of experience in medical device regulatory affairs, dossier preparation, and change management.
Available Positions
1. Regulatory Affairs Specialist
Location: Pune | Job Type: Full-time
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Key Responsibilities:
- Serve as a key point of contact for international regulatory filings and procedures.
- Support centralization of regulatory operations to enhance compliance and efficiency.
- Handle multiple regulatory projects simultaneously, ensuring deadlines are met.
- Assist in building a Regulatory Affairs center of excellence.
- Conduct team meetings and coordinate across multiple geographies.
Qualifications & Skills:
- 3–5 years of experience in international regulatory affairs.
- Expertise in Class I & II medical device dossier preparation.
- Engineering degree preferred, ideally in Biomedical Engineering.
- Strong interpersonal and communication skills.
2. Regulatory Affairs Operations Specialist
Location: Pune | Job Type: Full-time
Key Responsibilities:
- Assist and coordinate regulatory submissions for product licensing.
- Perform change management for labeling, manufacturing, and design compliance.
- Maintain comprehensive documentation for regulatory audits.
- Support regional and central RA teams in UDI/GTIN registration and device updates.
- Ensure regulatory submissions align with global standards and processes.
Qualifications & Skills:
- 5+ years of experience in MedTech regulatory affairs.
- Basic understanding of regulatory roles within Quality Systems.
- Bachelor’s degree in Biomedical Engineering, Health Sciences, Pharmaceutical, or equivalent.
- Strong analytical skills, quality mindset, and effective communication.
Benefits of Working at Philips
- Opportunity to work with a global health technology leader.
- Exposure to international regulatory affairs and cross-functional projects.
- Growth opportunities through centralized regulatory operations initiatives.
- Collaborative work culture with emphasis on learning and innovation.
How to Apply
Application Link for Regulatory Affairs Specialist
Application Link for Regulatory Affairs Operations Specialist
