Regulatory Inquiry Expert

Help transform Post Market Surveillance (PMS) and improve the lives of millions while contributing to Philips’s mission as a global leader in Health Technology.

As a Regulatory Inquiry Expert, you will be responsible for ensuring timely and accurate responses to regulatory inquiries from global Competent Authorities. You will collaborate with diverse teams within the Image Guided Therapy – Systems Business Unit to facilitate and develop responses in accordance with written procedures and global regulatory requirements.

Key Responsibilities:

• Ensure accurate and timely responses to regulatory inquiries from global authorities.

• Collaborate with Complaint Investigators, Business Experts, Clinical Experts, Market Experts, Vigilance Reporting Specialists, Engineers, Field Service & Application Engineers, and Manufacturing personnel.

• Coordinate with Business Experts and reportable complaint investigators to identify necessary information for inquiry responses.

• Review complaints to ensure all required information is available, determine if further investigation is needed, and track the investigation to completion.

• Draft, track, and submit regulatory inquiry responses, ensuring proper documentation and monitoring for continuous improvement.

• Maintain and improve tracking/control systems for regulatory inquiry responses.

• Manage intake of new inquiries by logging data into tracking systems, including Teams and SharePoint.

• You hold a Bachelor’s degree or higher in biomedical engineering, science, healthcare, or a related medical profession. (An Associate’s degree may be considered with at least 5 years of hands-on patient care or product servicing experience.)

• You have 4+ years of experience in the medical device industry or another regulated industry, preferably in Post Market Surveillance.

• You have 3+ years of experience in a relevant role, such as biomedical engineering, risk management, regulatory functions, product servicing, or developing responses to regulatory inquiries.

• You have a solid understanding of Complaint Handling, CAPA, Corrections and Removals, and global medical device regulations, including 21CFR Parts 803, 806, and 820, ISO13485, ISO14971, and ISO9001.

• You have knowledge of global post-market surveillance regulations, including 21CFR and MDD93/42/EEC.

• You possess strong attention to detail, excellent writing skills, problem-solving abilities, and effective communication skills.

• You are proficient in Microsoft Office applications. Experience with Philips medical devices, Trackwise Complaint Handling Tool, and Salesforce is a plus.

• You can successfully perform the minimum physical, cognitive, and environmental job requirements with or without accommodations.

• Collaborative Environment: Work alongside a dynamic and multidisciplinary team dedicated to regulatory excellence.

• Professional Growth: Gain access to training and development opportunities in a global organization.

• Global Impact: Contribute to regulatory strategies that support high-quality healthcare solutions worldwide.

• Hybrid Work: Enjoy a flexible work arrangement based on business needs.

For contract roles: You will work for Philips as a contract or permanent employee of a Randstad company, gaining access to benefits and career development opportunities.

Philips is a health technology company driven by the belief that every human matters. Our mission is to provide quality healthcare solutions that improve lives worldwide. By joining our team, you will be part of life-changing projects that make a real impact.

If you’re interested in this role and meet many—but not necessarily all—of the qualifications, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion.