Manager Regulatory Affairs Operations

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management
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Job Details
Company

Job Details

Responsibilities

• You will act as RAO Business Partner, working closely with Marketing and Development to manage development projects and changes from a 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, conformity assessment and resulting Declaration of Conformity based on global regulatory compliance
• Strategical and conceptional development of Regulatory Affairs Operations Department
• Support of by strategically and technical advice in regulatory issues
• Strategical planning, conceptional development and performance of trainings and mentoring in regulatory issues and needs with regards to the defined area of responsibility global regulatory product documentation and conformity assessment

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

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.

Company info

Website
https://barringtonjames.com/
Telephone
01293 776644
Location
The Galleria
Station Road
Crawley
West Sussex
RH10 1WW
United Kingdom
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