Regulatory Affairs Manager - Software Devices

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) in Medical Device Software you concentrate regulatory support for medical device and IVD software over the entire product life cycle and work on various tasks such as:

• Creation of technical documentation
• Ensuring compliance with EU requirements (93/42 / EEC, 98/79 / EC, 90/385 / EEC) and the new regulations (EU) 2017/745 and 2017/746
• Interactive collaboration with internal experts on all topics related to the CE marking of medical devices / IVDs (preclinical, clinic, QM etc.)
• Implementation and maintenance of regulatory SOPs within ISO 13485
• Close cooperation with international customers and notified bodies and competent authorities
• Development of creative solutions to meet customer needs in link with regulatory requirements

Knowledge and skills:

• Completed training or studies in software engineering or comparable educational background
• Experience with the key issues of a software development lifecycle, such as. Software requirements analysis, software architecture, detailed Software design, test (module, integration, system), maintenance
• Very good project management skills
• Very good knowledge of German and English

Ideally you should have knowledge in the following areas

:

• Practical experience in CE marking software
• Ensuring or implementing compliance with IEC 62304
• Experience with international registrations like 510 (k)
• Knowledge of IEC 60601-x and closely related standards such as ISO 14971 or IEC 62366
• Experience in the medical device or IVD industry, preferably in Positions in 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