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Job Information

Philips Senior Manager Regulatory Affairs (m/f/d) in Böblingen, Germany

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In this role, you have the opportunity to

Be involved in developing, modifying and executing company regulatory strategies and policies that affect immediate operations. Through combining human insights and clinical expertise, we aim to improve patient outcomes while lowering the burden on the healthcare system. Philips delivers advanced solutions for both health professionals, to meet the needs of patients, and empowered consumers for affordable healthcare whether in hospital or at home.

You are responsible for

  • Lead Patient Monitoring business unit regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and product changes

  • Lead individual contributors, formulating the medium term regulatory policy into a regulatory strategic plan

  • Give guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as CE Marking, product registrations, and clinical evaluations

  • Regularly interact with senior management and advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.

  • Responsible for working with Q&R Business Leader to prepare for compliance with new EU MDR (Medical Device Regulation)

  • Drive improvement in regulatory aspects of the Quality System May represent Philips in an international committee chartered to develop an applicable standard

You are part of

Monitoring/Analytics & Therapeutic Care (MA &TC) designs, and develops best-in-class monitoring solutions, telemetry, clinical measurements, and clinical decision support systems that simplify clinician workflow, improve financial outcomes and help improve and save lives.

The Quality & Regulatory department supports patient care and clinical Informatics products and solutions with focus on patient monitoring. We ensure worldwide product approval and compliance with all applicable Regulations and requirement.

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

  • Bachelor’s degree (Master’s or PhD preferred) preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry

  • Minimum of 10 years of management experience in the medical device industry and specifically in Q&R environment

  • Experience with successful preparation, submission and clearance of 510(k)s. Regulatory & technical competency with CE marking / technical files experience is strongly preferred

  • Strong English written and oral communications skills; German preferred

  • Proficient knowledge of medical device regulations (21CFR), FDA law, MDD/EU MDR, MDSAP and other global laws and regulations and standards

  • Understand LEAN concepts, methodologies and deployment

  • Demonstrated Management skills, preferable across multiple sites

  • Good interpersonal skills and strong communication skills, team player

  • May require limited travel

In return, we offer you

Working in the medical industry brings much fulfillment, as well as unique opportunities to grow. By taking pride in all you do and inspiring others around you to prioritize Quality above all else, you’ll be contributing to a higher Quality of life for billions and helping Philips deliver innovation that matters.

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.

Philips encourages people with a disability to apply.

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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