Senior Regulatory Inquiry Expert

Regulatory Inquiry Expert

Location: Best, Netherlands

Duration Assignment: 12 months (with possible extension)

Contract: via a Randstad company

Hours/week: 40

Monthly Salary: €4,800 - €6,800

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

When you choose to work at Philips, you’ll work on life-changing projects and contribute to innovative health technologies and solutions that improve billions of lives around the world.

Your role:

• Ensure timely and accurate responses to regulatory inquiries received from global Competent Authorities.

• Work with diverse stakeholders within the Business Unit (Image Guided Therapy – Systems) such as Complaint Investigators, Business Experts, Clinical Experts, Market Experts, Vigilance Reporting Specialists, Engineers, Field Service & Application Engineers, and Manufacturing personnel to develop responses to inquiries from regulators and competent authorities in accordance with written procedures and global requirements.

• Coordinate with Business Experts and reportable complaint investigators to determine the need for information required for drafting inquiry responses.

• Review complaints to ensure all necessary information for inquiry responses is present; determine if further investigation is needed and track investigations to conclusion.

• Write, track, and submit inquiry responses to the necessary authorities. Monitor and improve tracking/control systems for regulatory inquiry responses.

• Perform intake of new inquiries by logging data into the tracker, complaint database, Teams, and SharePoint.

• Identify gaps in complaint investigation or handling processes through your work on inquiries and support improvements.

• Lead (indirectly) the team of regulatory inquiry specialists, complaint investigators, and other specialists in activities such as daily management of inquiries and root cause analysis.

• Manage relationships with complaint handling and R&D stakeholders to drive quality improvements.

You're the right fit if you have:

• Bachelor’s Degree or higher in biomedical engineering, science, healthcare, or medical profession (an Associate’s degree may be considered for individuals with at least 5 years of hands-on patient care experience or experience with servicing or supporting similar products in the field).

• 6+ years of experience in the Medical Device or other regulated industry. Experience in Post Market Surveillance in the Medical Device domain is preferred.

• 5+ years of experience working as a biomedical engineer, risk manager, or in quality and regulatory functions, including developing responses to regulatory inquiries.

• Advanced understanding of Complaint Handling, CAPA, Corrections and Removals, and global medical device regulations, requirements, and standards such as 21CFR Parts 803, 806, and 820, ISO13485, ISO14971, and ISO9001.

• Background in global post-market surveillance regulations (21CFR, MDD93/42/EEC, and other applicable global regulations).

• Strong attention to detail, excellent writing skills, problem-solving ability, and the ability to communicate issues in a timely manner.

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

• Ability to perform the minimum physical, cognitive, and environmental job requirements with or without accommodation.

About Philips:We are a health technology company. We built our entire company around the belief that every human matters, and we won’t stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

In return, we offer you:For this project, you’ll work for Philips and become a contract or permanent employee of a Randstad company. As a contractor at Philips, you'll enjoy cutting-edge challenges and unexpected experiences that make you a more in-demand professional.

Why work on a project at Philips?If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise, and become an even more sought-after professional, you’ll find all that and more with project work at Philips.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.

Are you ready to take the next step?