Safety Compliance Manager
Location: NetherlandsSIRE 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 COMPANY
Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.
Large Medical Devices company.
ROLE DESCRIPTION
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.
RESPONSIBILITIES
- Lead all safety/regulatory affairs to ensure that the products/business comply with all regulatory requirements
- 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
REQUIREMENTS
- Experience in R&D
- 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
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 (about 10%)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.
