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Regulatory Affairs / QMS Manager - Microbiosensor Limited

Posted: 3 January 2018

Closing: 10 January 2018


Microbiosensor is a central Manchester based Medical Devices company developing disposable point-of-care diagnostics for microbial infections.  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 patients. The company anticipates filing a CE mark to permit EU sales for this device in Q2 2019.  Other applications for the technology in diagnosing the antibiotic sensitivities of urinary tract and wound care infections are at the laboratory prototype stage.

Microbiosensor is now looking to recruit an experienced QMS and Regulatory Affairs specialist to the team, to lead on developing the companies quality management system, technical file preparation, and the planning and submission of documentation to UK, European and US regulatory authorities.  We are looking for a self-motivated and goal-oriented individual with sufficient experience to help guide the company to its first product launch.

The successful candidate must be comfortable in an SME environment and the particular challenges and responsibilities of working within a small, dedicated team. 
Microbiosensor offers a competitive remuneration package, with the possibility of share options if key targets are met. The post is available immediately and is a permanent contract. Applicants should send a detailed curriculum vitae with a covering letter including a brief description of experience as well as the names and contact details of two referees to:

Email: nicola.cousins@microbiosensor.com
Closing date: 10th January 2018

REQUIRED EXPERIENCE / SKILLS

• At least 3-years’ experience of quality management systems (QMS) and regulatory affairs (RA)) within the Medical Device / IVD industry.

• Experience of building and implementing a QMS, encompassing product design, development and production. Direct experience of planning a QMS, preparing documentation and embedding it into a workplace.

• Good knowledge of ISO9001 and ISO13485 quality systems, including the planning and creation of some of:
o Quality Management Systems
o Technical Specifications
o Risk Analysis documents
o Usability Analysis documents
o Clinical Evaluation reports
o Compliance with Essential Requirements and Conformity Route Requirements
o Construction of Verification and Validation Reports
o Sterilisation Specification and Validation

• Experience of the preparation and submission of technical files and associated documentation for successful IVD or medical device approvals by the MHRA / EMA.

• 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.

• Ability to work independently and in small multi-disciplinary teams.

• Attention to detail and an enthusiastic, inquisitive, hard-working attitude.

NICE TO HAVE EXPERIENCE

• Interactions with Notified Bodies

• Experience representing companies to the regulatory authorities.

• Good knowledge of regulatory systems including the researching and authoring of GMP systems for subsequent approval by the EMA.

• Knowledge of FDA and other global device registration authorities

• Knowledge and experience of QA auditing including accreditation for auditing of clean rooms/manufacturing and sterilisation.

• Personally authored Technical Files, Design Dossiers and/or 510(k) s for medical devices or diagnostics

RESPONSIBILITIES

• Report directly to the Product Development Director.

• Responsibility for advising on, and building, quality and regulatory operations at the company.

• Support the development of colleagues and provide advice on in the implementation of quality management procedures and processes.

• Advise the technical team in their preparation and planning of scientific and technical work which will be required for regulatory submissions.

• Maintain awareness of the regulatory environment and ensure the company continues to comply with all regulatory standards going forward.

It is intended that the successful applicant will develop towards fulfilling the requirements of the IVD regulations in being the designated person responsible for regulatory compliance.

Microbiosensor