Manager Regulatory Affairs
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 Gelderland Netherlands.
Manufacturer of Medical Devices.
ROLE DESCRIPTION
- Monitor and ensure that the product portfolio is in line with current regulations in areas where the products are marketed.
- Providing records of the product portfolio in existing and new markets.
- Supporting the internal organization, including product development and marketing on regulatory aspects.
- Supporting the distribution network in the area of regulatory issues.
- implementing incident management.
- Identify problem areas within and / or outside the department, providing solutions for this and implementing improvements in accordance with applicable agreements.
RESPONSIBILITIES
Manager Regulatory Affairs is responsible for:
- Be aware and stay informed of all relevant regulatory requirements. Actively monitoring developments in the field of regulatory in all relevant markets and advice the management by showing reports and action plans.
- The complete product registration process. This includes coordinating, supervising and organizing registrations, type testing and product tests which are necessary to the admission comply.
- To support and advise on product ranges and market introductions in regulatory aspects. This includes: CE mark, MDD, FDA approval, certifications,
type testing, technical file, etc.
Supporting and advising the subsidiaries and external distributors in regulatory issues.
- The entire incident management process in accordance with established procedure (vigilance). Liaise with the inspection authorities (Competent Authorities) and Notified Bodies.
- Participation in standards committees (NEN / CEN / ISO), trade unions or groups related to the product;
- Coordinating and controlling the activities of the RA department to planned activities according to agreements expire. Conducting appraisal and assessment interviews.
The RA manager is ultimately responsible for the operation of the department as a whole.
REQUIREMENTS
- You have at least 5 years experience as an RA Manager in an international environment .
- You will have knowledge and understanding of the applicable national and international regulations
- You can set priorities and you are accurate.
- Excellent command of the English language is required.
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.
