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CY Partners Scientific Recruitment - Quality Assurance and Regulatory Affairs Manager

Job Title:
Quality Assurance and Regulatory Affairs Manager
Category:
Technical roles
Closing Date:
11/12/2023

Quality Assurance and Regulatory Affairs Manager

AMLo Biosciences

Contract: Permanent Opportunity

Location: Newcastle Upon Tyne (on-site or hybrid working available – minimum of 3 days a week on site)

Salary: £35,000 - £40,000

CY Partners Recruitment is delighted to be partnering with AMLo Biosciences in their search for a new Quality Assurance and Regulatory Affairs Manager! Situated in the state-of-the-art Biosphere centre in central Newcastle, AMLo Biosciences are an early-stage Biotechnology company dedicated to developing prognostic tests for oncology indications to improve patient welfare.

If you’re a specialist or senior QA/RA Officer seeking to progress and develop alongside an exciting Biotech company, then AMLo’s Quality Assurance and Regulatory Affairs Manager may be the next best step for you! You will be responsible for maintaining and improving the company QMS as well as the direct involvement in Regulatory projects and work, offering input and advice into regulatory projects focused on new product development in the healthcare diagnostic industry. 

Reporting to the Operations Director, you will be responsible for:

  • Maintaining ISO 13485 certifications and company QMS.
  • Supporting the development of the company’s regulatory strategic plan.
  • Drafting the company’s regulatory submissions, as well as managing their technical documentation.
  • Actively monitoring the regulatory environment, assessing the impact of new or changing regulations on the business.
  • Inputting QA/RA advise into new product design, building the existing team’s knowledge and experience.

About You:

  • Bachelors/Masters’ degree in a related scientific or engineering degree.
  • A minimum of 2 years' experience of constructing and maintaining technical files in accordance with Medical Device Regulations.
  • Experience leading external audits, particularly ISO 13485 audits.
  • Subject matter expertise in the understanding of regulations and compliance within healthcare diagnostics.
  • Excellent attention to detail and communication skills, including written ability, as well as the ability to work within a team environment.
  • A self-starter who can motivate themselves and others, with the ability to work independently and to their own initiative.
  • Desirable experience of being the QA/RA lead within new product development teams, regulatory processes in Europe, US (CLIA and/or FDA) and Australia and knowledge/experience of Software as a Medical Device/IVD.

If you are interested in this opportunity with AMLo Biosciences to become a Quality Assurance and Regulatory Affairs Manager, please apply online. Any queries can be directed to Kieran Martin at kieran.martin@cypartners.co.uk

The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. CY Partners Recruitment Ltd, trading as CY Partners is an Employment Business/Agency.

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