Regulatory & Quality Affairs Manage - QMS Medical Devices

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

Job Details

Area of responsibility:
As a regulatory affairs expert (m / f / d) for medical devices and quality management systems focus on regulatory support for medical devices during the entire product life cycle and are involved in a variety of projects and tasks involved, such as:

• Implementation of quality management systems according to EN ISO 13458: 2016,
• Maintenance of our internal quality management system (EN ISO 13485)
• Ensuring compliance with EU requirements according to MDR (EU) 2017/745
• Interactive collaboration with in-house experts covering all topics in the cover connection with the CE marking of medical devices (preclinical experts, clinicians, QM experts, etc.)
• Development of creative solutions to meet customer needs in Link with regulatory requirements
• Close cooperation with international customers and with notified bodies and competent authorities
• Compilation of technical documentation according to MDR 2017/745 Annex II

Knowledge and skills:

• Completed training or studies in the fields of natural sciences, Medical technology, engineering or comparable training background
• Experience in the CE marking of inactive medical devices e.g.
• Combination products (drug device or device drug), material Medical devices, catheters, implants or wound dressings
• Experience in the introduction and maintenance of quality management systems according to EN ISO 13485
• Experience in risk management (ISO 14971)
• Experience in the medical device industry, preferably in positions in the field Regulatory Affairs

and / or

Quality Management or at Notified Bodies

• Excellent project management skills
• High degree of teamwork
• Very good spoken and written German and English skills

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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