Job Details  
Advertiser: First People Solutions

Job Title: Quality & Regulatory Affairs Director
Rate:£60K to £70K Per Year
Description: Looking for a Quality & Regulatory Affairs Director within the Biologics industry? This position is based in Edinburgh, Scotland.

This is a great chance for you to work in an exciting team whilst gaining valuable experience within a highly regulated environment. You would be working with a fantastic Biologic & Device Manufacturer company based in Edinburgh. They’re looking for a Quality & Regulatory Affairs Director.

The company are ideally looking for someone who can start on a 6 month contract role and then will move into permanent, however the client would also take on someone that just wanted to contract for the first 6 months.

The rate on permanent would be around 60K - 70K & in the contracting period it would be around 3,500 per month, however the working days can be around 3-4 days per week when contracting.

As a Quality & Regulatory Affairs Director you will be responsible for

Job Description:

* To oversee, maintain and improve the current Quality Management System maintaining CE mark for Device(s) within EU territories, ISO13485 accreditation and FDA PMA in US for combination product (device / biologic)
* Preparation of regulatory submissions for EU, US FDA and rest of world for the imaging system combination product and other products as they become available
* To provide guidance and leadership for all matters related to quality and regulatory affairs.
* To support applications, amendments and supplements, and variations for device / product licences within EU, US, Canada and other territories.
* Ensures that all processes needed for the Quality Management System are established, implemented and maintained, including but not limited to: CAPA, complaint handling, design control, documentation control, internal audit, management review, nonconforming product, production and process controls, MDR, and field corrective actions.
* Communicates progress, problems, and plans. Elevates issues requiring attention to Corporate Management.

Qualifications Needed:

* 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 combination product (medical device + biologic) licence applications and maintenance
* Experience of managing and maintaining quality management systems preferably to ISO13485, 21CFR820 and US FDA biologics 21CFR600 series
* Auditing experience preferably to ISO13485, 21CFR820 and US FDA biologics 21CFR600 standards


* Experience of dental devices
* Lead Auditor qualification
* Experience of CMDCAS

If you’re interested then apply today!
Skills Required: Quality, Regulatory Affairs, Reg Affairs, Regulatory, Biologics, Medical Devices
Job Type: Permanent
Start Date:
Contact: Alana Bittles Contact E-mail: Click
Contact Tel: 0141 270 5006 Contact Fax:
Reference: AB1993 Added: 01-12-2017
  IMPORTANT: For jobs based in the UK it is unlawful to employ a person who does not have permission to live and work in the UK. Please ensure you have this permission before applying, unless the advert states otherwise.
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