Philips Senior Regulatory Affairs Manager in Eindhoven, Netherlands

Job Description

Job Title

Regulatory Affairs Manager

Job Description

Your challenge

The Regulatory Affairs Manager is responsible for the coordination and preparation of regulatory plans and document packages for regulatory submissions (FDA, Health Canada, EU, Asia, etc). The RA manager also provides strategic input during product creation process and contributes to the department’s overall regulatory strategy plan. At Philips, the RA Manager cooperates closely with Product Development, Clinical Science and Marketing and Sales.

Your responsibilities

Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.

  • Together with professionals from other departments and in other countries, translate regulations and standards into product requirements

  • Ensure product complaince to internal Philips policies and external regulations and standards

  • Responsible for the planning, coordination and preparation of document packages for regulatory submissions to the US, EU and/or Canada [e.g. 510(k) Pre-market Notifications, CE Marking, Health Canada].

  • Collaborate with worldwide colleagues regarding license renewals and updates

  • Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.

  • Communicate application progress to internal stakeholders

  • Maintain regulatory files and tracking databases as required

  • Communicate with regulatory agencies as needed

  • Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways Your team You are part of a team of Regulatory Affairs Specialists based in the HTC in Eindhoven. You will report to Regulatory and product Compliance Director,. ISE is a multicultural team and they are all enthusiastic people striving for the best regulatory compliancy. We are looking for

  • Bachelors/Master of Science degree in a software, technical, or biomedical discipline

  • Minimum of 4-6 years of experience in medical device regulated environment.

  • Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide

  • Excellent working knowledge of medical device regulations, FDA law, MDD, other global laws and regulations

  • Experience in supporting international registrations (FDA) and clinical investigations (preference)

  • Knowledge of the CFDA requirements. (preference)

  • Excellent verbal and written communication skills (English)

  • Enthusiastic, self-motivated regulatory professional

  • Good communicator and team player who is able to work in a flexible and goal oriented environment

  • Analytical / systematic / logical thinker

  • Helicoptor view ensuring that the pieces of the puzzle fit content and process wise

  • Structured way of working

  • Problem solving and time management skills Compensation Grade 70

In this role, you have the opportunity to

Coordinate and prepare regulatory plans and document packages for regulatory submissions (FDA, Health Canada, EU, Asia, etc). The RA manager also provides strategic input during product creation process and contributes to the department’s overall regulatory strategy plan. You will be working very closely with Product Development, Clinical Science and Marketing & Sales. If you like to explore different options within laws, and operate in a broad realm of ativities with different stakeholders, then you are our next regulatory partner.

You are responsible for

  • Developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy;

  • Together with professionals from other departments and in other countries, translating regulations and standards into product requirements;

  • Ensuring product complaince to internal Philips policies and external regulations and standards;

  • Planning, coordinating and preparing document packages for regulatory submissions to the US, EU and/or Canada [e.g. 510(k) Pre-market Notifications, CE Marking, Health Canada];

  • Collaborating with worldwide colleagues regarding license renewals and updates;

  • Reviewing and approving engineering changes, advertising, promotional items and labeling for regulatory compliance;

  • Communicating application progress to internal stakeholders;

  • Maintaining regulatory files and tracking databases as required;

  • Communicating with regulatory agencies as needed;

  • Creating an environment of positive feedback, and using professional concepts and company objectives to resolve complex issues in creative and effective ways.

You are a part of

You are part of a truly global and multicultural team that strives for the best regulatory compliancy. You will report to Regulatory and Product Compliance Director based in Drachten, Netherlands.

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

  • Bachelor/Master of Science degree in a software, technical, or biomedical discipline;

  • Minimum of 5 years of experience in medical device regulated environment;

  • Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide;

  • Excellent working knowledge of medical device regulations, FDA law, MDD, other global laws and regulations;

  • Experience in supporting international registrations (FDA) and clinical investigations (preference);

  • Knowledge of the CFDA requirements is preferred;

  • Excellent verbal and written communication skills in English;

  • Enthusiastic, self-motivated regulatory professional;

  • Good communicator and team player who is able to work in a flexible and goal-oriented environment;

  • Analytical / systematic / logical thinker;

  • Helicopter view ensuring that the pieces of the puzzle fit content and process wise;

  • Structured way of working; Problem solving and time management skills.

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.

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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .