Job offer

Reference number: 1500644

Manager Regulatory Affairs Medical Devices (m/f/d)

Company

For our client, a global Health Care company located in the area of Frankfurt, we are currently looking for this permanent position:

Main tasks

• Coordination of Post-Market Surveillance activities
• Compilation of Post-Market Surveillance Report and Periodic Safety Update Reports according to MDR
• Coordination of Clinical Evaluation Reports
• Support and Coordination of the production units with regards to updates and harmonization of the technical documentation to assure compliance with the Medical Device Regulation (MDR)
• Act as a link between production unit, marketing, supply chain and vigilance
• Supervision and harmonization of labelling activities between the different production units
• Provision of documents for registration of irrigation solutions worldwide
• Support requests from local affiliates on the medical device portfolio of the Business Unit
• Monitoring the regulatory surrounding, by e.g. checking the authority websites for new guidance document
• Monitoring the changes in legislation/updates
• Provide regulatory support to other departments, e.g. SCM, Marketing
• Being a project team member in development projects for combination products

Requirements profile

• Coordination of Post-Market Surveillance activities
• Compilation of Post-Market Surveillance Report and Periodic Safety Update Reports according to MDR
• Coordination of Clinical Evaluation Reports
• Support and Coordination of the production units with regards to updates and harmonization of the technical documentation to assure compliance with the Medical Device Regulation (MDR)
• Act as a link between production unit, marketing, supply chain and vigilance
• Supervision and harmonization of labelling activities between the different production units
• Provision of documents for registration of irrigation solutions worldwide
• Support requests from local affiliates on the medical device portfolio of the Business Unit
• Monitoring the regulatory surrounding, by e.g. checking the authority websites for new guidance document
• Monitoring the changes in legislation/updates
• Provide regulatory support to other departments, e.g. SCM, Marketing
• Being a project team member in development projects for combination products

Is this position interesting?

I am looking forward to hearing from you!


Doris Ehrmann

Kleen Linnebo & Partner Unternehmensberatung GbR

Fon: +49 281 3008424

Mobil +49 173 700 49 44

Mail: d.ehrmann@klp-personal.com