SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
The companyOur client is a professional Medical Devices organization, based in Noord-Brabant Netherlands. is a developer, manufacturer and reseller of Medical Devices in class I, II and III.
Role descriptionThe departmet of the company is focusing on the development of medical and non-medical lifestyle products. It is responsible for the development and realization of new product propositions. This innovative site is looking at a very challenging growth task to bring more new ideas to the global market.
A key department in this site is the “Quality and Regulatory” Department. The Quality & Regulatory 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 company guidelines. Next to that the Quality &Regulatory team ensures that the site development processes meet internal standards, ISO9001, ISO13485 and FDA regulations.
Responsibilities- Lead all safety/regulatory affairs to ensure that the products/business comply with all regulatory requirements and internal 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 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- Experience in R&D of durable consumer products
- Experience in electrical device regulation and certification (IEC60601)
- 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%)