Regulatory Affairs Manager

Functieomschrijving

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Pharmaceutical, Medical Devices and Finance organisation, based in Utrecht Netherlands.The CompanyThis organisation contributes to the improvement of high- quality, however accessible and affordable, global healthcare. They focus on the development of technologies to improve clinical care, invasive and general surgery.

Role DescriptionIn your role as Regulatory Affairs manager, you will be completely involved with creating strategies and developing plans to make sure that products are compliant in relation to required documentation and legislation for Europe. You will lead various types of audits among which internal, and distributor audits. You will lead your team in acting up on these audits, performing CAPA’s and creating tools for compliancy. Next to that, you will be the key person to contact for the establishment and maintenance of relationships with internal and external authorities.

Responsibilities• Key contact person concerning Regulatory Affairs for internal and external stakeholders among which authorities and
notified bodies
• Creating awareness and spread of knowledge regarding RA related topics and procedures
• Supportive and advisory role as team lead, and for subsidiaries of the organisation
• Overviewing the ongoing changes and points of improvement for the Quality Management System and relevant, required
documentation
• Maintenance and controlling of the required regulation standards and legislation
• Follow up on the latest developments for Medical Device regulation and creating strategies to apply these regulations
• Development of trainings and exchange of knowledge across teams and other departments
• Leader during internal and external audits from the beginning to the end of the process, and making reports of these audits

Requirements• Bachelor of Life Sciences
• Minimal 2 years of experience within the Medical Device industry
• Minimal 3 years of experience within a strongly regulated environment
• Lead Auditor certification
• Proven experience in building and maintenance of relationships with internal and external authorities
• Excellent knowledge of Medical Device Regulation and standards for the European, Middle Eastern, African and Canadian
market
• Fluency in English and Dutch
• Magnificent organisational and analytical skills
• Excellent team player and communicator

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.

 

Aanbod/arbeidsvoorwaarden
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