Head of Regulatory Affairs, Personal Health

4 weken geleden

Eindhoven, Noord-Brabant, Nederland Philips Voltijd
Job TitleHead of Regulatory Affairs, Personal HealthJob Description

Head of Regulatory Affairs, Personal Health

Support the innovation of services/products focusing on improving people's life. You lead a global Regulatory Affairs (RA) team delivering Regulatory Intelligence and product compliance for all 3 Business Units and formally represent the Philips Consumer Lifestyle B.V. Legal Manufacturer entity. You will also lead a team of international market Regulatory Affairs enabling worldwide market access of the Personal Health product portfolio. You will report to the Vice President RA and take part in the Leadership team on RA and be member of the Philips PH extended Leadership team. Your focus will be on household appliances, consumer Medical Devices and Cosmetics, Food Contact, Toys (Baby care) and overall Product Safety and compliance.

Your role:

  • Regulatory Affairs, Safety & Compliance of consumer products/services including medical and cosmetic products. As a legal manufacturer, you make sure that all Philips PH products being released are in compliance with all relevant safety and environmental policies and regulations by implementing and setting requirements, conditions and enablers.
  • Representing Philips PH in the lobbying/other discussions with European and other national governments and industry associations and influencing standardization bodies in the scope of product safety, product performance and efficacy. Preventing surprises of unknown legislation resulting in sales or reputation damage.
  • Preparation of regulatory strategies for business and alignment with regulators. Ensuring that all products (including medical) are aligned with legislation or regulations and Philips policies. Facilitate speed-to-market, to achieve all pre-market timelines and landmarks.
  • Preparing safety policy, keeping it aligned with new regulations and standards, having it approved, deploying and implementing these policies. Representing Philips to authorities in case of safety incidents or alleged product non-compliance. Initiating sales stops or recall of products from the market.
  • Ensuring a motivated and proficient team. Defining and implementing accurate organization and budget, hiring right people and ensuring that and projects are accurately running.
  • Advising product and solutions teams to ensure timely, effective and efficient transition to new requirements. Mentoring and training others to optimally do the same.
  • Ensure worldwide market access and compliance to local regulatory requirements

You're the right fit if:

  • Master's degree (Engineering or Medical/ biomedical background)
  • A minimum of 8 years' experience in RA in an International environment of which at least 5 years in Medical Devices (Class 1 and 2) is required
  • FDA and EU MDR experience is a must
  • Affinity with Cosmetic, Product Safety and Food Contact
  • Experience in Project management (within Regulatory Affairs) is an advantage
  • Strong communicative and stakeholder management skills
  • Prepared to travel up to 20% globally
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

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.

  • Learn more about our business.
  • Discover our rich and exciting history.
  • Learn more about our purpose.
  • Read more about our employee benefits.

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.

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