Senior Manager Vigilance Reporting (m/w/d)

ab sofort

71032 Böblingen


Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better

Help transform Post Market Surveillance (PMS), which will help improve the lives of millions of people while advancing Philips’s journey as a global leader in Health Technology.

You will use your vigilance reporting experience and expertise to lead a team of Vigilance Reporting Specialists and implement globally compliant and Philips standardized adverse event reporting policy and processes.

You are responsible for

  • Enforcing standardized and simplified adverse event reporting processes
  • Providing leadership and subject matter expertise to a team of Vigilance Reporting Specialists who are responsible for world-wide adverse event reporting decision making and report submissions.
  • Introducing and implementing adverse event reporting processes and tools required to ensure global regulatory compliance, quality, and patient safety.
  • Managing compliance to FDA regulations and other Regulatory Agencies.
  • Managing the oversight and review of adverse event reports globally
  • Actively participating in inspections and questions relating to the operation of complaint handling operations, processes and procedures in coordination with all other applicable company groups.
  • Establishes an effective Management Review process, including routine reporting.
  • You are a part of

    As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interactions with Philips Business Group and the leadership. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being, and care for people around world.

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

  • Master’s or bachelor’s degree with > 5 years’ experience managing adverse event reporting activities with a preference towards bachelor’s degree or higher in biomedical engineering, science, healthcare, or medical profession.
  • 5 years previous experience working as a biomedical engineer/risk manager OR in a licensed/certified capacity in a health care role such as an RN, NP, PA, MD, Respiratory Therapist, Radiation Technologist, Ultrasound Technologist, CT technologist, etc. OR previous experience with servicing or supporting Philips’s products in the field OR previous experience working as a Vigilance Reporting Specialist
  • 7-10 years’ experience Medical Device and or other regulated industry
  • Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO1497, and ISO9001
  • Global post market surveillance regulation (21CFR, MDD93/42/EEC and other applicable global regulations), ISO14971 Risk Management.
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