Regulatory Affairs and Product Compliance Manager

Koninklijke Philips N.V.
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Wendy van IJs avatar
Wendy van IJs senior recruitment consultant

As a Regulatory Affairs manager you will develop global regulatory strategy, and if needed connect to regulatory SMEs. Participate in and advise cross-functional teams on applicable regulations, requirements, and standards, as applicable to products in scope. Create product regulatory plan and support creation of standards and compliance plans and labeling plansElicit regulatory requirements. Review development documentation and plans to ensure that the information required for submissions and product compliance is adequate. Plan, generate, and coordinate regulatory submissions for product licensing per regulatory plan. Coordinate conformity assessment plans required to support regulatory submissions. Review and approve product labeling and product related marketing communications. Actively monitor changing regulatory environment relevant to the product portfolio with the support of Philips network and external sources. Represent RA-SCR in product safety risk management activities.

Your team

Central RA-SCR team in it's delegated role of Legal Manufacturer, is accountable for product Safety, Compliance and Regulatory Intelligence for the Personal Health cluster. It owns the related processes and competence and represents the Legal Manufacturer on matters of product regulatory compliance and safety towards competent authorities. Your tasks focus on the support of the new Consumer Health Business Development Teams.

As a member of the central Personal Health SCR team, your job is to ensure that products of Consumer Health Business portfolio comply with external regulations and standards and with company product safety & compliance policies. You will be guiding the business through the borderline and rapidly changing regulatory landscape

Functie-eisen

To succeed in this role, you should have the following skills and experience:

  • You have a degree in Software, Electrical, Biomedical or Mechanical Engineering, combined with a strong interest in Regulatory Affairs and Compliance.
  • You have a proven record of accomplishment in product development and Safety & Compliance domains in international, multi-disciplinary development projects (5 years for Master, 7 years for Bachelor).
  • Experience in multiple product regulatory domains (medical device, consumer products, personal protective equipment) is a plus.
  • Proven analytic capabilities and product knowledge a system thinking
  • A network oriented mind-set and ability to interact with different business functions at all levels.
  • Project management skills.

Competenties

As a Regulatory Affairs Manager you have the following skills:

  • conceptual, analytical, data driven
  • hands-on, getting things done mentality
  • a subject leader and also a team player
  • a good communicator
  • skilled in managing interpersonal process always looking for perfection and do not accept poor results quality oriented and have a ditto mind-setwilling to travel internationally/intercontinentally when needed.
  • fluent in the English language

Arbeidsvoorwaarden

In return we offer you a chance to serve a bigger purpose: The work you do every day contributes to innovative health technologies and solutions that help improve billions of lives every year, even yours. This creates unexpected moments when your work and personal life come together in meaningful ways.

Bedrijfsinformatie

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by 2025 delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Next to that you will be joining a nice work environment with fun colleagues that are always willing to help each other!

Yacht is a contractor for highly educated professionals (BSc, MSc, or PhD) who’ll work on site and innovate together with our customers to find smart solutions. Working as a high tech professional within Yacht means you will work on interesting and challenging long term projects for our clients.

Solliciteren

Inclusiviteit en diversiteit

Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.

Wendy van IJs avatar
Wendy van IJs senior recruitment consultant

Vragen?

recruiter Wendy van IJs

Wendy van IJs

senior recruitment consultant

Het sollicitatieproces

1  van 5

Je sollicitatie en cv worden doorgenomen door Wendy van IJs

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Binnen 5 werkdagen ontvang je een reactie

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Is er een match, dan plannen we een persoonlijke kennismaking

We onderzoeken samen jouw ambitie en mogelijkheden

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Daarna word je (eventueel) voorgesteld bij onze opdrachtgever

Wanneer de klik er is, ga je starten bij je nieuwe uitdaging!

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Afhankelijk van het soort dienstverband (interim, zzp of vast), ontvang je van ons een aanbod