Senior Manager - Quality Assurance and Regulatory Affairs
Quality Assurance and Regulatory Affairs - Medical Device Organisation - Cambridge
Your new company
I am working with a fast growing, family run business who specialise in the development of Medical Device products. They are based 15 minutes away from Cambridge and are currently looking to take on a Senior Manager of Quality Assurance and Regulatory Affairs to join their fast growing team. This is a great opportunity for somebody who is eager to really develop their career and take it to the next level, the role holds a lot of autonomy. There is lots happening in the business in terms of expansion and acquisitions and they would require somebody who can really work in a fast paced environment, and be able to hit the ground running.
Your new role
The Senior Manager of QA and RA is a very high profile member of the operations management team, who will hold full responsibility for the Quality Assurance and Regulatory Affairs activity across the business. You will be responsible for ensuring compliance to the appropriate Regulatory standards (ISO13485 and Medical directive 93/42/EEC and cGMP). You will effectively manage both Quality Assurance and the technical services personnel so that compliance is maintained.
What you'll need to succeed
To be considered for this opportunity you should have:
A degree in a Life Science discipline (or equivalent)
Strong leadership experience with a quality compliance background
Experience operating within ISO13485 and the medical device directive (93/42/EEC)
Significant regulatory experience which includes compiling technical files and design dossiers
Good understanding of Lean Manufacturing and six sigma, would be desirable to hold a minimum of a yellow belt
What you'll get in return
There is lots of scope within the role, the business has lots of plans for expansion so there will be lots of development opportunities to progress up the career ladder. The role offers up to £58,000 plus additional 25 days holiday and pension scheme.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
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