Do you want to bring innovative consumer products to the market as fast as possible? Are you interested in making the difference in personal health consumer products?
You will be responsible to ensure that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers. Within this role you will be linked to the Mother and Childcare innovation area.
Lead all safety/regulatory affairs to ensure that the products/business comply with all regulatory requirements and Philips policies
Manage safety and regulatory approval teams/labs/activities
Carry out root cause analysis in case of safety and non compliances according 8D approach
Ensure all relevant regulatory requirements are implemented and verified/validated, in development projects and OEM ODM products
Facilitate risk assessments
Lead projects with significant Safety and Regulatory content
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
A key department in this site is the “Quality and Regulatory” Department (Q&R). The Q&R-team ensures that all products meet next to the medical and non-medical regulations and standards, the performance and reliability requirements needed for the product category and overall guidelines. Next to that the Q&R team ensures that the site development processes meet internal standards, ISO9001, ISO13485 and FDA regulations.
We are looking for
You have a Bachelors degree in Electrical, Biomedical 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.
Experience in R&D of durable consumer products
Experience in electrical device regulation and certification
Proven analytic capabilities and product knowledge
A network oriented mindset and ability to interact with all business functions at all levels
Project management experience/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 production is typically outsourced to Asia or Eastern Europe, this job requires some travelling (about 10%)
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