Regulatory Affairs Senior Consult

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details
Company

Job Details

We are partnered with an international service provider for medical devices and in vitro diagnostics. Their core competence is the CE marking for the European market. They support numerous medical device and IVD manufacturers to successfully meet the requirements for CE labelling and thus market access within the European Union

The company headquarters only a few kilometres from Freiburg and Basel (Switzerland) in a small spa town surrounded by forest and vineyards.
They look after their customers and projects very individually and generate a large part of their business through recommendations and long-term cooperation with customers.

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

Apply now to learn 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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