QA/RA Manager


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

22nd May 2015

Location

Edinburgh

Salary/Rate

£35000 - £40000

Type

Permanent

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QA/RA Manager

My client, a Medical Device company based in Scotland are looking for a QA/RA Manager to join their company on a flexible basis. They are open to a full time or part time permanent employee so it might be a good role for someone who needs flexible hours.

The role:

* To maintain and improve the current Quality Management System maintaining CE mark for devices and ISO 13485 accreditation

* To provide guidance and leadership for all matters related to quality and regulatory affairs.

* To support application for device / product licences within EU, US, Canada and other territories.

Expected Qualifications

* At least degree level in appropriate area (Life Sciences, Biology, Quality management). Ideally with additional professional qualifications

Essential Experience:

* At least 5 years of experience within GxP setting

* Experience of managing and maintaining quality management systems preferably to ISO 13485

* Auditing experience preferably to ISO13485 standard

* Experience of medical device licence applications and maintenance

Desirable

* Experience of FDA 21CFR820 and 600 series

* Experience of dental devices

* Lead Auditor qualification

* Experience of PMA and CMDCAS

If you are interested then please get in touch by sending your cv or contacting Bethany on 02077587311

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