Philips

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Originele vacaturetekst

Product Regulatory Affairs and Compliance Manager

Job Description

In this role, you have the opportunity to

Ensure that Personal Health products comply with external regulations and standards and with company product safety & compliance policies as a member of the central RA-SCR team.

You are responsible for

Verifying Philips Personal Health products comply with all the relevant regulations, standards and safety and environmental policies before they are released to the market; clarifying and deploying new country regulations, and manage device listings and registrations on behalf of Legal Manufacturer.

Responsbilities:

  • 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.
  • Handle challenges from surveillance authorities and other external parties on the compliance of Philips Personal Health products in alignment with appropriate stakeholders
  • Handle potential non-compliances, inform and monitor the relevant innovation sites on solving the issue and review and approve the final result
  • Instruct and support the innovation sites on the new process and tooling
  • Monitor the compliance process KPI’s and pro-actively improve
  • Maintain existing regulatory filings/ licenses, managing updates and related change control processes
  • Supporting regulatory intelligence team on deployment of global regulations impacting PH portfolio
  • Evaluating the effect of changes in global regulations and standards for PH products together with relevant parties

You are a part of

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.

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 the medical device domain is a plus
  • Proven analytic capabilities and product knowledge – system thinking
  • Fluent in the English language
  • Network oriented mind-set and ability to interact with different business functions at all levels
  • You are conceptual, analytical, data driven, and also hands-on, getting things done mentality
  • You are a subject leader and also a team player
  • You are a good communicator skilled in managing interpersonal processes

In return, we offer you

We welcome you to a challenging, innovative environment with great opportunities for you to explore.

Our benefits are very competitive and designed around your preferences:

  • A market conform salary
  • 25 Days of leave and the possibility to purchase up to 20 extra days off annually
  • A variable bonus based on both Philips results and personal performance
  • Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
  • Solid company pension scheme and attractive collective health insurance package
  • Opportunity to buy Philips shares and products with discount
  • Healthy work-life balance

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 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. Learn more by watching this video.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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Dienstverband:
fulltime
Type vacature:
Intern

Vaardigheden

  • Er is geen minimale opleiding vereist

Wat wij bieden

Contract:
Fulltime