Regulatory Affairs experts

Job description

Job Title

Regulatory Affairs experts

Job Description

There's never been a better time to join the Philips Quality and Regulatory team. One of the largest transformations currently happening at Philips, since 2015 we've been creating a revolution in the way Quality is built in to the Philips culture. As part of this global transformation, we're reducing the number of Quality Management Systems, introducing strong clinical standards and creating a culture where quality becomes a competitive advantage. Sound like something you'd love to be part of? If you feel that spark of excitement, if we trigger the perfectionist in you, then we'd love to hear from you!

We currently have 159+ quality and regulatory career opportunities available online and expect many more to come.

If you are interested in a career in one of the following fields, please apply with a CV and a motivational letter.

We are looking for several Regulatory affairs experts on different levels.

This is not a concrete open position, but as we are frequently looking for people like this, we would like to recieve your CV so we can look for options for you.

In these roles, you have the opportunity to

Be responsible for the coordination and preparation of regulatory plans and document packages for regulatory submissions (FDA, Health Canada, EU, Asia, etc). The specialist also provides strategic input during product creation process and contributes to the department's overall regulatory strategy plan. At Philips Digital Pathology Solutions the RA Specialist cooperates closely with Product Development, Medical Affairs and Marketing and Sales. We are looking for candidates with strong Regulatory Strategy Development and Product Management RA experience.

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.
·  Planning, coordination and preparation of document packages for regulatory submissions to the US, EU and Canada [e.g. 510(k) Pre-market Notifications, PMAs, Product Reports/Supplements, CE Marking, Health Canada].
·  Assuring regulatory compliance throughout the full life cycle of the device, including defect and complaint reviews for program teams, provides guidance to the team on risk assessment and required corrective actions to meet regulatory requirements.
·  Coordinating in pre submissions and participate in meetings with FDA and other 3rd party external regulatory agencies like SFDA
·  Participating in FDA inspections and notified body audits
·  Creating an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways

You are a part of

a worldwide business for total digital pathology solutions encompassing an Ultrafast Scanner for microscope tissue slides, a pathology viewer/workstation/PACS and teams up with healthcare systems to gain insights, based on which integrated solutions can be developed, aiming to improve the quality of diagnosis and to make it easier to analyze data and personalize patient care. DPS aims at leveraging multiple Philips assets and capabilities (brand, market channel, technology) for establishing the total solution and being the 1st to market to establish a dominant market position. The market launch of the first solutions was in the first half of 2011 in the USA and UK, followed by the rest of Europe and Asia.

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

·  Bachelors/Master of Science degree in a technical, biomedical or business discipline.
·  A couple of years relevant working experience in a regulated environment (medical device, pharma, automotive, aerospace, biotech) related to Regulatory Strategy Development and Product Management RA experience (required)
·  Experience with determining the CONTENT of the submissions (required)
·  Experienced in design control processes (requirement)
·  Excellent working knowledge of medical device regulations, FDA law, MDD, other global laws and regulations (requirement)
·  Experience with successful coordination, preparation and submission of 510(k), PMA, or international documents for registration and/or marketing of medical devices worldwide (preference)
·  Experience in supporting international registrations (FDA) and clinical investigations
·  Software background is a strong plus
·  Experience in the IVD world is a plus
·  Excellent verbal and written communication skills (English)
·  Good communicator and team player who is able to work in a flexible and goal oriented environment
·  Structured way of working
·  Approx. 15% travel annually

In return, we offer you

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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?

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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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