Medical Device Consultant

1 week ago


Glasgow, United Kingdom QCS International Ltd Full time

**Management Consultant for ISO 13485 Medical Devices**

This post is ideally suited to a quality or regulatory associate in the medical device sector who may have 2- or three-years’ experience and who is now ready to expand their knowledge and exposure to a wider range of product types and services. Whilst work will begin on UKRP services we plan to develop the appointed consultant to widen their experience and knowledge on the regulatory framework, ISO 13485, auditing and, eventually training services.

This is a new and exciting opportunity for a medical device specialist to expand their contacts, broaden their experience and become an active and vital member of staff within our small medical device team.
- A degree or equivalent in a scientific or engineering discipline.
- Work experience in the medical device sector
- Some knowledge and understanding of the regulatory framework for medical devices in the UK, EU and beyond
- A full UK driving licence

It would be useful, but not essential to also
- Have experience implementing, using and can demonstrate knowledge of ISO13485 (a knowledge of ISO9001 is also an advantage)
- Be dynamic with a strong customer focus, exceptional communication and computing skills
- Experience with auditing
- Experience in Product Conformity Documentation, i.e. CE Marking or FDA Applications
- The ability to speak a European language.

The post can involve travel to locations throughout the UK and abroad. QCS are taking a flexible approach to this position and will consider part-time and full-time options

Remuneration will be commensurate with experience.

**Job Types**: Full-time, Part-time, Permanent

**Job Types**: Full-time, Permanent

**Benefits**:

- On-site parking

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Glasgow: reliably commute or plan to relocate before starting work (preferred)

**Education**:

- PhD (preferred)

**Experience**:

- Regulatory Affairs: 3 years (preferred)

Willingness to travel:

- 25% (preferred)

Work Location: One location



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