Job Title: Regulatory Affairs Manager
Location: Pune, India
Employment Type: Full-time, Regular
Philips is seeking a Regulatory Affairs Manager to ensure that its medical devices and healthcare solutions meet global regulatory standards. This role directly impacts patient safety, product approvals, and innovation, collaborating across multiple functions including Regulatory Affairs, Quality Assurance, R&D, Clinical Affairs, Marketing, and Product Management.
As a Regulatory Affairs Manager, you will oversee compliance throughout the product lifecycle, drive submissions for FDA, EU MDR, ISO, and other global frameworks, and provide guidance on regulatory strategy to ensure timely approvals.
Lead regulatory submission activities, including US FDA 510(k), CE marking, EU MDR, ISO 13485, ISO 14971, 21 CFR 820, Health Canada, and CDSCO submissions.
Manage multiple high-stakes regulatory projects simultaneously, ensuring adherence to timelines and global regulatory requirements.
Collaborate with cross-functional teams to provide regulatory guidance throughout product development and commercialization.
Ensure compliance with medical device rules, CAPA, and other regulatory requirements.
Support international collaboration and maintain awareness of evolving regulatory frameworks.
Experience: 10–15 years in regulatory affairs within the medical device industry, with a proven record of successful submissions.
Education: Bachelor’s degree in Pharmacy, Biology, Chemistry, or Engineering; Master’s degree or Regulatory Affairs Certification (RAC) preferred.
Skills: Strong expertise in FDA, EU MDR, ISO standards, 21 CFR 820, Health Canada, CDSCO, CAPA, and global regulatory strategy.
Personal Attributes: Ability to manage multiple complex projects under tight deadlines, strong communication, analytical, and leadership skills.
Philips is a global health technology leader dedicated to improving access to quality healthcare. Employees benefit from health and wellness programs, work-life balance initiatives, international collaboration opportunities, and exposure to advanced medical technologies.
Philips fosters a culture where every employee can make a meaningful impact on patient lives while growing professionally.
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