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Manager Safety & Compliance

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Job Description

A key department of our client’s organisation is the “Quality and Regulatory Department (Q&R)”. The Q&R team ensures that all products meet the medical and non-medical governmental regulations and international standards, and the performance and robustness requirements. Next to that the Q&R manager ensures that the site development processes meet internal standards, ISO9001, ISO13485 and FDA regulations, and that there are SLA’s with the various production sites and suppliers which ensure that these regulations are met.

Candidate responsibilities
You will be responsible for ensuring that all products to be released to te market comply with all the relevant safety and environmental policies, regulations and international standards. Within this role you will be linked to one or more of our innovation areas;

  • Lead all safety/regulatory affairs to ensure that the products/business comply with all regulatory requirements and policies.
  • Manage safety and approbation teams/labs/activities including medical devices
  • Carry out root cause analysis in case of safety and non compliances according 8D approach
  • Implement all relevant regulatory requirements in development projects, OEM/ODM products and verify and validate designs regarding these requirements
  • Lead safety risk assessments according the GPSD (hazard based safety risk assessment)
  • Represent our client in international regulatory bodies on specific subjects
  • Establish relationships with certification bodies worldwide (such as DEKRA or UL) and coordinate the approbation process via these certification bodies
  • 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.

Requirements


You have a Masters degree in Electrical (preferred) or Mechanical Engineering, combined with a proven track record (>5 yrs.) in product development and Safety & Compliance domains in international, multi-disciplinary, consumer product development projects.

You have:

  • Experience in development of consumer products
  • Experience in regulatory areas (product safety & compliance to international regulations; ideally also for medical devices)
  • Proven analytic capabilities and Product knowledge
  • A network oriented mindset and ability to interact with all business functions at all levels

    You are:
  • 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 production is typically outsourced to Asia or Eastern Europe, this job requires some travelling.

Locatie

Eindhoven

Contactpersoon

Joost Assink
M: (06) 8300 4130
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