Philips Hiring Regulatory Affairs Specialist | medical device

Philips Hiring Regulatory Affairs Specialist – Apply Now!

Are you an experienced regulatory professional looking for a new opportunity? Philips, a global leader in health technology, is hiring a Regulatory Affairs Specialist in Pune, India. If you have expertise in medical device regulations and compliance, this could be your next career move!

About Philips

Philips is dedicated to improving global healthcare by developing innovative medical technologies. With a mission to enhance lives through meaningful innovation, Philips is a trusted name in the healthcare industry, offering cutting-edge medical solutions worldwide.

Job Role: Regulatory Affairs Specialist

Key Responsibilities

• Develop, coordinate, and prepare regulatory submission packages for various global markets (FDA, EU, Health Canada, Asia, etc.).
• Ensure compliance with medical device regulations, including 510(k) Pre-market Notifications, CE Marking, Health Canada approvals, and MDR compliance.
• Collaborate with international teams on license renewals and product updates.
• Review and approve engineering changes, advertising materials, and labeling for regulatory compliance.
• Communicate regulatory application progress to stakeholders and regulatory agencies.
• Maintain regulatory tracking databases and documentation.
• Support UDI/EUDAMED and GTIN management.
• Assist in local item creation and ERP setup with a focus on local market requirements.

Required Qualifications & Skills

Education

• Bachelor’s degree in Software, Technical, or Biomedical disciplines.

Experience

• 2-4 years of experience in a medical device regulated environment.
• Hands-on experience in regulatory submissions and registrations.
• Experience with 510(k) submissions or international regulatory documentation.
• Strong knowledge of FDA regulations, EU MDR, and global compliance standards.
• Preferred experience in supporting international registrations and clinical investigations.

Preferred Certifications & Skills

• Regulatory Affairs Certification (US, EU, CA, or Global Regulatory Affairs) – preferred.
• Understanding of NMPA (China) regulatory requirements – preferred.
• Excellent verbal and written communication skills in English.
• Strong problem-solving and time management skills.
• Self-motivated, detail-oriented, and a team player.

Application Deadline: February 24, 2025

How to Apply

Interested candidates can apply online through the official Philips careers portal. Click here to apply.