Job Information
Philips Product Regulatory Affairs and Compliance Manager in Drachten, Netherlands
Product Regulatory Affairs and Compliance Manager
As a member of the central regulatory compliance team of Personal Health (CRC), your job is to assure that Personal Health products comply with external regulations and standards and with company product safety & compliance policies. In this role you shall monitor external regulations and co-develop, maintain and implement policies and practices that ensure Personal Health entities are compliant and able to efficiently gain and sustain market access for products and in particular medical devices.
Your role:
Support innovation sites in eliciting regulatory requirements and establishing standards and compliance plans.
Review product compliance plans and the subsequent evidence in the product pre-release phase.
Execute product compliance verification and regulatory clearance activities.
Support management of complaints with potential regulatory impact, inform and monitor the relevant innovation sites on solving the issue and review and approve the final complaint resolution.
Handle challenges from surveillance authorities and other external parties on the compliance of Philips Personal Health products in alignment with appropriate stakeholders.
Act as product compliance process expert, ensuring adequacy and definition of the process and work instructions.
Instruct and support the innovation sites on the new processes and tooling.
Monitor the compliance process execution and pro-actively improve.
Supporting regulatory intelligence team on deployment of global regulations impacting PH portfolio and processes.
UDI implementation PH RA coordinator.
Evaluating the effect of changes in global regulations and standards for PH products together with relevant parties Domain owner for Medical Devices.
Contribute to the definition of Personal Health Compliance framework.
You're the right fit if:
You have a degree in Software, Electrical, Biomedical, Mechanical or related Engineering, combined with a pragmatic quality mindset and eye for detail
You have at least 10 years of regulatory compliance experience in product and medical device development business environment for international markets
You possess broad expertise and experience with interpretation and implementation of global medical device regulations and market access requirements, and with interactions with regulators and competent authorities (NB/EUMDR, FDA, TGA, HCA,..)
You are familiar with other compliance domains of relevance for conformity of Personal Health portfolio (childcare, household, toys, EMC/EMF, sustainability, etc.)
You have affinity with process and tool management
You have network-oriented mind-set and ability to effectively communicate with different business functions at all levels
You have developed project management skills, proven analytic capabilities and conceptual and system thinking.
You are conceptual, analytical, data driven, and have a hands-on, getting things done mentality
You are willing to travel internationally/intercontinentally when needed (traveling percentage 5-10% on yearly base)
You are fluent in the English language
To apply for this role, it is a requirement to reside in the Netherlands at the time of your application
How we work together
We believe that we are better together than apart. For this office-based team, 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 commitment to diversity and inclusion here.