Post Market Surveillance specialist

Job Title

Job Description

Your role:

• Manage all Post Market Surveillance activities for the Grooming & Beauty medical devices (e.g. IPL devices).
• Serves as the primary liaison for internal and external stakeholders, handles all aspects of complaint investigations and resolutions, coordinates communication between stakeholders and ensures timely and effective resolution of issues.
• Stay up to date with medical device regulations and standards (e.g., 21 CFR part 820, MDR, ISO 13485, IEC60601-01) in relation to Post Market Surveillance.
• Works with limited supervision and broad guidelines.
• Enforces standards for appropriate coding to records as input for the complaints process, ensures all systems and tools are updated, and reviews and updates complaints as new codes become available.
• Supports Complaint handlers with customer response letters (CRL) or internal responses, as appropriate, upon concluding the investigation, and escalates complex matters to appropriate channels for further assistance and resolution.
• Heads the end-to-end investigation of complaints, analysing findings, and presenting a concise overview of the inquiry process.
• Escalates complex matters to senior stakeholders for further assistance and resolution.
• Cultivates strong relationships with internal and external stakeholders, ensuring effective resolution of post-market issues and continual improvement in product quality and safety.
• Prepares and presents regular management reports on improvement initiatives outcomes, trends, and areas of concern to management.
• Supports stakeholders during the execution of quality system- and product audits and inspections.

You're the right fit if:

• You have a master’s or bachelor’s degree in medical sciences, healthcare management, industrial engineering, mechanical engineering, mechatronics, or equivalent.
• You have at least 3-5 years work experience in multidisciplinary teams. Preferably in a quality, Post Market Surveillance, and/or product development environment.
• You take ownership for implementation and management of requirements coming from medical device regulations and standards.
• You have affinity and/or experience with Post Market Surveillance and/or Complaint handling processes.
• You have strong affinity and/or experience with medical device regulations and standards (e.g., 21 CFR part 820, MDR, ISO 13485, IEC60601-01).
• You have good communication and influencing skills in English and preferable a basic knowledge of the Dutch Language.
• We believe that we are better together than apart. This means working in-office at least 3 days per week.

How we work together
We believe that we are better together than apart. For this role, this means working in-person at least 3 days per week.

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 the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.

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