Job offer

Reference number: 20201947

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

Company

-> Are you experienced in Regulatory Affairs of Medical Devices and Technical Documentation?

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

Main tasks

  • Update and maintenance of the technical documentation in line with current legal requirements (e.g. MDD 93/42, MDR 2017/45, ISO 13485) and internal SOPs
  • Coordination of the production units with regards to update and harmonization of the annexes to the technical documentation
  • Leading role in definition of common templates for annexes to the technical documentation
  • Act as an expert for all questions related to the technical documentation for internal stakeholders (e.g. marketing, productions units, supply chain)
  • Assure compliance of label and IFU with legal requirements and initiate respective label - updates
  • Responsible for oversight in all applicable standards and assure state of the art of relevant standards for the products
  • Close interaction with design functions and marketing
  • Key contact for the implementation of document management system for the products
  • Provision of documents for registration of irrigation solutions in non EU countries
  • Support requests from local affiliates on the medical device portfolio of the Business Unit
  • Use of regulatory affairs database (RegTrack)
  • Provision of information to Eudamed
  • Participation in internal and external audits for all topics related to the technical documentation
  • Support of post-market surveillance activities and clinical evaluation
  • Monitoring the regulatory surrounding, by e.g. checking the authority websites for new guidance documents
  • 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

  • Successfully completed university degree in Medical Engineering, Life Sciences, Medicine, Pharmacy or related fields
  • 4 or more years of professional experience in the field regulatory affairs for Medical Devices
  • Scientific and technical experience for Medical Device development and life cycle management
  • Basic knowledge in regulatory affairs for Pharmaceuticals
  • Well-organized, team-minded, solution oriented way of working
  • Good communications skills to work in a interdisciplinary, multi-national and virtual team
  • Thorough knowledge of ISO 13485, requirements, ISO 14971 (Risk Management), Medical Device Directives (MDD) and Medical Device Regulation (MDR) requirements, knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
  • Good knowledge in MS Office and general affinity to work with electronic systems
  • Willingness to continuously develop regulatory expertise and areas
  • Fluent in English and German, knowledge of another foreign language desirable
  • Strong communication and presentation skills
  • Ability to adapt to changing circumstances
  • Experience in intercultural project teams
  • Willingness to travel occasionally

Contact

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