Regulatory Affairs Operations Manager - Medical Devices
- Employer
- Barrington James
- Location
- Germany (DE)
- Salary
- €75,000-€95,000
- Start date
- 12 Sep 2019
- Closing date
- 25 Sep 2019
View more
- Discipline
- Regulatory Affairs, Compliance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
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!!!
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB
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