Philips Regulatory Affairs Manager in Zaventem, Belgium

Manager, Regulatory Affairs, IGTD International

Job Profile: Q&R Manager, Grade 70

Location: Belgium

Your challenge

Your challenge will be to organize and drive international registrations. This will involve working with distributors, registration agents and internal Philips support staff. This will also require a solid process and communication with the U.S. based international team working with you. You will need ot be a confident advisor on approval and regulatory compliance and participate on European Management Teams.

Organize international Regulatory work in coordination with the U.S. team. This will require you to set up and drive a clear and transparent process.

This role is part of the management team (MT) reports solid line to the Head of Regulatory, IGTD based in the U.S. and have a dotted line to the Head of International, IGTD. This role may require substantial travel within Europe and occasionally to the U.S.

Main purpose of job

  • drive international regulatory registrations

  • organize the international registration process in close coordination with the U.S. based team

  • clearly communicate with the international business partners to drive global expansion

  • act in alignment with policies and procedures to drive high quality and integrity

  • compliant,effectiveand efficientRACAprocesses.

  • necessary relationswithrespective regulators in the applicablemarkets are builtandmaintained.

Key areas of responsibilities (KARS) for this role include:

  • Advise businessRACAteams on applicable regulations, requirements, andstandardsthrough the developmentofregulatory plans.

  • RACAprogramsto ensure the highestlevel of compliance.

  • marketsubmissionstrategy fornewproducts/solutions(toincludedefinition of all deliverablesand/orlocalizationrequired).

  • generate,manageandcoordinate regulatorysubmissions for product/solutionlicensing.

  • deploy systemsto ensurethattheinformation requiredforallrequiredreports, productregistrationcertificate renewals andsubmissionsareclearlyidentifiedcan be easyretrieved.Thisincludes the creation of a central locationforregulatoryteamsanddistributorsto accessregulatory documentsand certificates for worldwideproductregistrationsandapprovals

  • Review andapprovelocalizedproduct/solutionlabelingandproduct/solution-relatedmarketing communicationsandensure thatallmedicalandtechnicalclaims areunderpinnedwithevidenceobtained by businessQ&R.

This position requires:

  • strong international regulatory expertise

  • ability to create processes, tools and communication plans across the organization

  • hands on manager who can drive independently

  • this role will have direct reports, so management experience with clear mechanisms to develop strong regulatory experts will be required

  • proven ability to partner with team members across the globe

This position requires a minimum of a technical Bachelor's degree, preferably in a life-scientific discipline, and a minimum of 10 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.

We are looking for:

A self-motivated and independent driver who is particularly talented building strong relationships around the world, which often includes in a virtual environment.

Specific skill requirements for this role include:

This position requires a Bachelor’s degree, preferably in a life-scientific discipline, and a minimum of 10 years of experience working in regulatory affairs within a global medical device industry.

Our offer

This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to 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. When you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, and protected veteran or marital status.

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 of5-7yearsofexperienceworkingin regulatory affairs within a global medical deviceindustry

  • ExtensiveknowledgeofMDD,MedDev’s, FDA QSR’s, ISO 13485,andother for the market EMEAapplicableregulations

  • 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.

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.