Daily new life sciences jobs

 

Interim Quality Assurance & Regulatory Affairs Manager

Share on social media:


SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

The company

Our client is a professional Medical Devices organization, based in Gelderland Netherlands. is an innovative company which is developing a revolutionairy new surgical medical device. The development is almost finalized and the market introduction is only a few months away

Role description

Due to the temporary leave of the current QA/RA Manager, the position of Quality Assurance and Regulatory Affairs is open for a period of 4 months. Your role involves the setting up of a QMS according to ISO13485 and FDA CFR 820. You will be the centre of the Quality related items, and your sparring partner will be the chief of development. You will also be involved in the ongoing development and improvement of the device.
This generalist function will also contain regulatory activities. As mentioned the medical device is weeks away from market introduction, so the company is focussing on obtaining a CE-mark and in a later stadium also the 510(k) approval.
The role is focussing on pre-market Quality and Regulatory Medical Devices.

Responsibilities

- Setting up compliant QMS according ISO13485 - FDA CFR 820
- Formulating SOP and working instructions
- Being the Lead regarding the compliance for EC, UL, FDA
- Experience with DEKRA is a pre

Requirements

- Technical, Medical, Engineering Bachelor
- Experience in QA Medical Devices - class 2/3
- In depth knowledge in QMS and compliance systems
- Good experience in verification and validation of Medical Devices
- Good documentation experience
- Fluent in English
- Experience with Notified Bodies



Job alert

  • No registration required
  • Stay up-to-date on the latest jobs

SIRE Life Sciences

Ref. number: 32140
Listed by: SIRE Life Sciences
Listed on: 20-07-2017
Country: The Netherlands
Region: Gelderland
Employment: Freelance
Expertise: 6 - 10 years
Location Type: Home
Language: English
Sector: Medical Devices
Specialisation: Quality
Secondary Benefit: Laptop

Search again

Related jobs

Dechra Pharmaceuticals Manufacturing
Pharmaceutical Development Manager M/V

The Netherlands
Permanent
General Management

Naut van Osnabrugge
Associate Lab Managing Scientist (Freelance)

The Netherlands
Freelance
Research & Development

Rowin van der Zwaan
IS/IT Business Analyst

The Netherlands
Permanent
Medical

Michiel den Uijl
Quality Assurance Manager

The Netherlands
Permanent
Quality

Anastasia de Vries
Jr. Technical Salesperson

The Netherlands
Permanent
Sales

Contact

THE NETHERLANDS

Spiegelhof
Herengracht 466
1017CA Amsterdam
+31 (0) 20 658 9800

BELGIUM

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

GERMANY

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

Product Price

SIRE Life Sciences® uses cookies to improve our website and your user experience. By clicking any link or continuing to browse you are giving your consent to our cookie-policy.