Regulatory Affairs Manager - IVD Expert

View more categories
View less categories
Discipline
Regulatory Affairs
,
Compliance
Hours
Full Time
Contract Type
Permanent
Experience Level
Management
Save
job
Click to add the job to your shortlist
You need to
sign in
or
create an account
to save a job.
Send job
Job Details
Company

Job Details

Area of ​​responsibility:

As a regulatory affairs expert (m / f / d) for in vitro diagnostic medical devices (IVD), you concentrate on regulatory support for in vitro diagnostics and companion diagnostics (CDx) over the entire product life cycle and work on a variety of

Tasks such as:

• Ensuring compliance with EU requirements (IVDD 98/79 / EG, IVDR 2017/746)
• Creation of technical documentation
• Interactive collaboration with internal experts on all topics related to CE marking of IVDs (preclinical experts, clinicians, QM experts, etc.)
• Implementation of quality management systems, e.g. according to EN ISO 13458: 2016 or MDSAP
• Close cooperation with international customers as well as notified bodies and competent authorities
• Develop creative solutions to meet customer needs with regulatory requirements

Knowledge and skills

:

• Completed training or studies in the fields of natural sciences, Medical technology, engineering or comparable training background
• IVD-specific experience with key regulatory issues

Affairs / QMS:

• CE marking of IVD products (preferably both reagents and also instruments)
• Quality management systems (EN ISO 13485)
• Very good knowledge of German and English
• Excellent project management skills

Ideally you should have knowledge in the following areas:

• List A / B products
• Analytical performance features (CLSI, ISO 18113-1)
• Clinical performance evaluation
• Experience in the medical device industry (especially in the areas of IVD, CDx), preferably in positions in the field of regulatory affairs and / or Quality management
• Experience with Notified Bodies

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
Share this job
Facebook
Twitter
LinkedIn
Send job
Save
job
Click to add the job to your shortlist
You need to
sign in
or
create an account
to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.
Create alert
Back to top

Jobseeker

Find a job
Job alerts
Search companies
Careers advice & news

Recruiters

Advertise a job
Pricing
Contact us (Recruiters/Employers)
Find out more

PharmiWeb.jobs

About Us
Contact Us (Job Seekers)
Terms of use
Privacy
Facebook
Twitter
LinkedIn
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings. The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.

mehr...

zur Vakanz

Weitere Jobs von PharmiWeb