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Senior Regulatory Affairs Specialist (m/f/d) (EN)

[5634]
Studium, Drug Regulatory Affairs Manager, Pharmacovigilance Manager, Medizintechnik, Kardiologie

Our client is a major player in the market for innovative products in the treatment of heart disease. The company develops and distributes modern medical products in the field of cardiology around the globe.   To support their expanding Team we are looking for a: Senior Regulatory Affairs Specilaist (m/f/d) MedTech Germany Tasks and Responsibilities ·Regulatory responsibility for the Middle East region, Eastern Europe including Russia, Brazil, South Korea, Indonesia and deputy role for Canada, Australia, Japan within the Global Life Cycle Management Group of the Regulatory Department. ·Preparation and processing of registration documents within the product development regarding international requirements as per above defined regions and in partnership with the executive management. ·Maintenance of technical product documentation within the Regulatory Department. ·Responsible for national components of approval procedures and projects. ·Responsible for international approval projects; compiling of all necessary documents for international registrations; change notifications, registrations and support for the whole process; regular status updates. ·Maintenance and updating (changes notifications, renewal) of registrations (life-cycle-management) and assurance of  reliable and punctual completion. ·Ensuring of high-quality processing of requests of authorities and compliance of legal requirements in the medical device area. ·Cooperation within the interdisciplinary team for implementation and realization of new regulatory requirements. ·Creation of gap analysis for new regulatory requirements. ·Implementation and support of external certification audits as well as planning, implementation and documentation of internal and supplier audits. ·Coordination of interface between the departments Regulatory Affairs and Development ·Participation in the interdisciplinary team for planning, contributing, documentation and coordination of CAPA, Change Management and Product Labelling. ·Maintaining eSENGO database, creating Product Sales Approval and approving Delivery Notes after investigation.  Requirements/ Qualifications ·Diploma, certificate or other evidence of formal qualification, awarded on completion of an university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline ·Professional experience in regulatory affairs or in quality management systems relating to medical devices ·English knowledge CEF (Common European Framework) Level: B2.2 You will be offered ·The company will offer you an interesting job in a team of people who like to work together and always focus on helping our customers to save and improve patient’s lives with innovative and highest quality products. If you feel attracted by this job feel free to get in touch with Osmarina Pereira at Optares Medical via osmarina.pereira@optares.de or by phone under +49 441 21879-31

Our client is a major player in the market for innovative products in the treatment of heart disease. The company develops and distributes modern medical products in the field of cardiology around the globe.  

To support their expanding Team we are looking for a:

Senior Regulatory Affairs Specilaist (m/f/d) MedTech
Germany

Tasks and Responsibilities
  • Regulatory responsibility for the Middle East region, Eastern Europe including Russia, Brazil, South Korea, Indonesia and deputy role for Canada, Australia, Japan within the Global Life Cycle Management Group of the Regulatory Department.
  • Preparation and processing of registration documents within the product development regarding international requirements as per above defined regions and in partnership with the executive management.
  • Maintenance of technical product documentation within the Regulatory Department.
  • Responsible for national components of approval procedures and projects.
  • Responsible for international approval projects; compiling of all necessary documents for international registrations; change notifications, registrations and support for the whole process; regular status updates.
  • Maintenance and updating (changes notifications, renewal) of registrations (life-cycle-management) and assurance of  reliable and punctual completion.
  • Ensuring of high-quality processing of requests of authorities and compliance of legal requirements in the medical device area.
  • Cooperation within the interdisciplinary team for implementation and realization of new regulatory requirements.
  • Creation of gap analysis for new regulatory requirements.
  • Implementation and support of external certification audits as well as planning, implementation and documentation of internal and supplier audits.
  • Coordination of interface between the departments Regulatory Affairs and Development
  • Participation in the interdisciplinary team for planning, contributing, documentation and coordination of CAPA, Change Management and Product Labelling.
  • Maintaining eSENGO database, creating Product Sales Approval and approving Delivery Notes after investigation. 

Requirements/ Qualifications

  • Diploma, certificate or other evidence of formal qualification, awarded on completion of an university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline

  • Professional experience in regulatory affairs or in quality management systems relating to medical devices

  • English knowledge CEF (Common European Framework) Level: B2.2

You will be offered

  • The company will offer you an interesting job in a team of people who like to work together and always focus on helping our customers to save and improve patient’s lives with innovative and highest quality products.

If you feel attracted by this job feel free to get in touch with Osmarina Pereira at Optares Medical via osmarina.pereira@optares.de or by phone under +49 441 21879-31


date_range 13.06.2022 update Permanent
Regulatory Affairs Drug Safety Zulassung Pharmacovigilance


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