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Regulatory Affairs Manager
- Regulatory Affairs
- CE, Medical Device
About Our Client
Our Client strives to become the leading provider of bio materials and medical implant solutions by improving access to next generation technologies, products, and health care services across global markets, with emphasis on high-growth countries. Due to proven products growth we are currently searching for a Regulatory Affairs Manager.
Main activities and responsibilities;
- Manage RA projects, deliverables and activities
- Lead and develop a RA team to a high level of competency
- Ensure compliance with all applicable standards and regulatory requirements for the product portfolio and manufacturing processes
- Co-ordinate compliance activities during regulatory inspections and represent the company with customers and relevant European, US and other international notified bodies
- Oversee and execute product registration and process changes
- Further develop and maintain the corporate regulatory strategy
- Collect, register and maintain technical files for products, in accordance with applicable laws and regulations
- Liaise globaly with local sites on regulatory and RA issues
- Successfully dealing with and managing relevant regulatory agencies with emphasis on EC, USFDA, ANVISA, India and C-FDA
- The Regulatory Affairs Manager reports directly to the Legal and RA Director. Depending on your preference you will be working out of our Nijmegen and/or Amsterdam site.
- Actively collaborate with internal business partners spread over the different entities within our group of companies.
The Successful Applicant
- Bachelors or Masters degree
- Management potential and/or two years of management experience
- Between three and six years of experience in a regulatory environment in the E
- Experience in the medical devices sector, preferably class 3 implantable medical devices
- Experience in the human tissue products sector is a plus
- Excellent knowledge of regulatory standards and their impact on product quality and compliance (i.e. GMP guidelines, ISO 13485, European Directive 2004/23)
- Good understanding of the EU MD Directives and EU MD Regulations.
- Expert in quality systems (i.e. change control, CAPA, deviations, etc.)
- Outstanding command of the English language (written and spoken)
- Good project management skills combined with hands on mentality
- Manager, self-starter, influential, methodical, systematic, detail oriented, strong communicator, analytical, problem solver, deadline-oriented, independent combined
What's on Offer
The Company offers a professional environment in a growing and ambitious family owned organization. With a young, dynamic, international and open culture, there is much attention for the development of staff and opportunities to grow. In addition company provides a competitive fixed salary, a bonus scheme, pension and laptop.