Regulatory Affairs Operations Manager - Full Time - Germany

Location
Germany (DE)
Salary
€75,000-€95,000
Posted
12 Sep 2019
Closes
12 Oct 2019
Ref
AW RAO
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

I am currently working with a global leader based in southern Germany, pioneering healthcare products and solutions and making an impact in millions of people’s lives around the world on a daily basis. Together we are looking for a regulatory affairs manager looking to progress further in their career to join an operations team.  

Responsibilities:

  • Act as a RAO business partner
  • Work closely with Marketing and Development to manage projects and changes from an RA perspective
  • Coordination of the internal RA functions and support in the transfer projects in order to jointly make the technical documentation MDR capable
  • Global supervision and enhancement of regulatory product documentation
  • Strategical and conceptional development of RAO department
  • Support by strategically and technical advice in regulatory affairs
  • Strategic planning, conceptional development and performance of trainings and mentoring in regulatory issues

Requirements:

  • Master’s degree in life-, natural- or technical sciences- or equivalent education
  • 5+ years’ experience within the field of health care industry
  • Knowledge of/experience in active and non-active medical devices, technical documentation, regulatory product documentation, conformity assessments and post-market surveillance
  • Strong knowledge of and experience in global regulatory requirements for medical devices, and personal protective equipment with regards to marketability
  • Ideally knowledge and experience in European and Germany regulatory requirements for drugs, biozid products and chemicals
  • Knowledge of business processes and global quality management systems In medical device industry e.g. ISO 13485, 21 CHR 820 and more
  • Fluent in English – German basic knowledge

If you think that you have the skill set required to make my shortlist please get in touch sooner rather than later!!!

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