QUALITY MANAGEMENT & REGULATORY AFFAIRS MANAGER

ABOUT THE COMPANY

Microbiosensor is an ISO13485 accredited medical device company developing point-of-care IVDs for diagnosing microbial infections and antibiotic sensitivities.  Our strategy is to develop simple disposable devices that target high-value market niches, where there is a clear unmet need for improved infection control. The nearest to market application for this technology is an in vitro diagnostic (IVD) for renal dialysis and liver cirrhosis patients.  The company anticipates filing a CE mark to permit EU sales for this device in Q1 2022, with an FDA approval to follow shortly afterwards. 

THE ROLE Microbiosensor is looking to recruit a Quality Management Systems (QMS) / Regulatory Affairs (RA) manager to help the company maintain and develop its quality management system, compile technical files, and plan and submit documentation to UK, European and US regulatory authorities. 

We are looking for a self-motivated and goal-oriented individual who will help coordinate the company’s regulatory activity in support of its first product launch.  The successful candidate must be comfortable in an SME environment and the challenges and responsibilities of working within a small, dedicated team. This opportunity might suit an experienced candidate who would welcome both the freedom and responsibility which comes with working in an SME.

Microbiosensor offers a competitive remuneration package, with the potential for share options. The post is available immediately as a full-time or part-time position (flexible working is an option for the right candidate). Salary £55-£60k.

Applicants should send their curriculum vitae with a covering letter (including a brief description of experience and two referees) to: jobs@microbiosensor.com.  Deadline–midnight Sun 26th September.          

  ESSENTIAL EXPERIENCE / SKILLS

• Experience of technical file preparation for CE-mark submission.
• Experience of quality management systems (QMS) and regulatory affairs (RA) within the Medical Device / IVD industry.
• Knowledge of ISO13485 quality systems.
• Involvement with successful IVD or medical device applications to the MHRA / EMA / FDA.
• A strong scientific and /or engineering background.
• Ability and flexibility to balance multiple tasks, meet priorities and deliver within timelines.
• Strong communication skills, both oral and written with good attention to detail.Ability to work independently and in small multi-disciplinary teams.
• Experience of technical file preparation for FDA 510k submission (desirable).