Regulatory Affairs Manager
Philips Lighting
31 dagen geleden

Job Description

In this role, you have the opportunity to

Organize and drive international registrations in this newly created role! You will come in and have a recognized voice to drive and witness exciting, transformational changes.

You will be empowered to drive high quality, ground-breaking innovations with a globally recognized, premium brand behind you.

You are responsible for

  • Driving international regulatory registrations of new and existing IGTD (Image Guided Therapy Devices) products and solutions
  • Developing and implementing the regulatory strategy in close cooperation with local stakeholders (marketing, key customers and industry representation bodies) and with the U.
  • S. based international team

  • Clear communication with the international business partners to drive global expansion
  • A compliant, effective and efficient RACA processes.
  • Building and maintaining necessary relations with respective regulators in the applicable markets
  • Maintaining existing regulatory filings / licenses, managing updates and related change control processes
  • Working with distributors, registration agents and internal Philips support staff
  • Leading a small team of Regulatory Affairs Specialists
  • You are a part of

    Philips Volcano, a Philips business, which is a global leader in physiology and intravascular imaging for coronary and peripheral applications.

    The business also offers a suite of peripheral therapeutic devices. This is part of Philip’s industry leading solutions to help clinicians to decide, guide, treat and confirm the right therapy for each patient in real-

    time during image-guided therapies (IGT).

    You will be part of the management team (MT) and will report solid line to the Head of Regulatory IGTD based in the U.S.

    and have a dotted line to the Head of International IGTD

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

  • A technical Bachelor's degree, preferably in a life-scientific discipline
  • Minimum of 5-7 years of experience working in regulatory affairs within a global medical device industry
  • Extensive knowledge of MDD, MedDev’s, FDA QSR’s, ISO 13485, and other for the market EMEA applicable regulations
  • A comprehensive understanding of the diverse worldwide medical device regulations, the experience to know how to successfully apply those regulations in an efficient, effective and compliant manner
  • Shown experience in understanding consequences of new and changing regulations to markets and business groups and effectively and actively transferring this knowledge and understanding to all applicable partners to ensure timely compliance with these regulations and guaranteeing continuous market access
  • A self-motivated and independent driver who is particularly talented building strong relationships around the world, which often includes in a virtual environment.
  • Ability to work effectively in multicultural teams and to work across a broad range of audiences.
  • In return, we offer you

    We welcome you to a challenging, creative environment with excellent opportunities for you to explore.

    Our benefits are very high-reaching 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
  • Confirmed 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.

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