Philips Regulatory, Safety and Compliance Manager in Amsterdam, Netherlands
You will guide and support the business and innovation teams in always doing the right thing while developing and marketing our innovative Population Health Management solutions for global market. You will navigate through the landscape of medical and borderline products and create regulatory plans for solutions comprising hardware, software and services.
You will ensure that all products to be released comply with all the relevant regulations and safety and environmental policies by implementing requirements and enablers.
As a Regulatory, Safety & Compliance manager you will:
Lead all safety/regulatory affairs to ensure that the products/business comply with all regulatory requirements and Philips policies
Advise business on marketing claims and create regulatory plans
Implement all relevant regulatory requirements in development projects, OEM/ODM/CM products and verify and validate designs regarding these requirements
Facilitate hazard based safety risk assessments
Establish relationships with certification bodies worldwide (such as Dekra or UL) and coordinate the approbation process via these certification bodies
Manage safety and regulatory approval activities
Carry out root cause analysis in case of safety incidents and non-compliances according to 8D approach and support event reporting activities
Lead projects with significant Safety and Regulatory content
Represent Philips in international regulatory bodies on specific subjects
Report and discuss trends in product roadmaps that could require pro-actively lobbying or building up knowledge about requirement or establishing relationships with authorities and/or certification bodies
You will be part of the regulatory team dedicated to the Business Group Population Health Management (PHM).
In January 2016, Philips announced a reconfiguration of our businesses to bring together our software assets and patient care expertise within a cluster named Connected Care & Health Informatics. As part of this, we created the new Business Group Population Health Management, which combines our activities in Personal Health Solutions, Hospital to Home, Home Monitoring, Connected Digital Platforms & Products (CDP2) and our newly acquired company Wellcentive.
As Philips, we are uniquely positioned to help reshape and optimize population health management, and will maximize this opportunity and our capabilities in this area by developing solutions that combine our activities and capabilities in these business units into sophisticated connected solutions.
Our Business Group aims to deliver impactful programs to multiple cohorts within a population. The key enablers to deliver population health management solutions that enable continuous health are strategic consulting, analytics and enabling technology.
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:
We offer 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
You have a Masters degree in Software, Electrical, Biomedical or Mechanical Engineering, combined with a proven track record (>5 yrs.) in product development and Safety & Compliance domains in international, multi-disciplinary, medical device development projects.
Experience in R&D of software solutions and/or durable consumer products
Experience in medical device regulation (EU, FDA)
Proven analytic capabilities and product knowledge
A network oriented mindset and ability to interact with different business functions at all levels
Project management skills
Conceptual, analytically strong, data driven, and also hands-on
A strong leader and a team player. You are an excellent communicator and motivator, skilled in managing interpersonal processes
Courageous and able to continuously challenge the status quo, with a strong desire to improve organizational effectiveness structurally
Always looking for perfection. You don't accept underperformance or poor results. You have a quality mindset
Since your teams are located at several continents, this job requires some travelling (about 10%)
Please share your resume and best moment in Recruitment with us. After a pre-selection process on your resume you will receive an invite for an introduction meeting by phone. If positive, you will be invited for (face-to-face) interviews.
If you have any remaining questions regarding this vacancy, please do not hesitate to contact Annette van Kamp-Rustenburg on tel +31-625714986