Leader Regulatory Affairs (m/w/d)

Leader Regulatory Affairs (m/w/d)

Job Title: Leader Regulatory Affairs (m/w/d)
Contract Type: Permanent
Location: Thüringen, Germany
Salary: Negotiable
Start Date: ASAP
Reference: DP 280819_1566997692
Contact Name: Daniel Perkins
Contact Email:
Job Published: August 28, 2019 14:08

Job Description

Leader Regulatory Affairs (m/w/d)

Medical Devices


My client located in Thüringen is an international medical technology manufacturer, who offer a wide range of unique and innovative products to the global market. You will have the opportunity in this role to step into a leading position that offers an attractive salary, internal and external training, flat hierarchies and short decision paths. This will most certainly be a positively challenging task in a forward-thinking company.

Your Role:

  • Leading a team of 6/7 (RA / QM / QS)
  • Ensuring an effective implementation of DIN EN ISO 13485, MDR
  • Continuous development of the QMS
  • Creation and maintenance of the technical documentation, taking into account the applicable standards and guidelines (medical devices class I-IIb)
  • Planning, coordination and implementation of national and international approvals for medical devices
  • Participation in product development/project management and in the product life-cycle with regulatory topics
  • GAP analysis for changes to standards, including the definition of measures
  • Participation in the planning, implementation and evaluation of clinical studies

Your Profile:

  • Successfully completed studies in a technical of life science related field
  • At least 3 years professional experience within Regulatory Affairs for medical devices (or Quality Management/Assurance)
  • Sound knowledge of the medical device industry as well as the relevant standards/guidelines
  • Strong leadership skills

+49 89 2109 4906