Senior Regulatory Affairs Specilaist

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 externalcertification 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.

Anforderungen

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

Wir bieten

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.

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