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Regulatory Compliance Manager

Employer
Reed Talent Solutions
Location
London
Salary
40876.00 - 45998.00 GBP Annual
Closing date
12 Jun 2023

View more

Sector
Quality Control
Role
Manager
Contract Type
Permanent

The Regulatory Compliance Manager supports the Quality and DDEU/IVD programme in High Containment Microbiology, working with the divisional and UKHSA Quality Teams, Technical Managers and laboratory teams in complying with regulatory affairs, achieving, and maintaining high quality performance and supporting continual improvement in service delivery in all processes in accordance with UKHSA policies and procedures. The post will support compliance activities at both Colindale and Porton sites.

Location

This opportunity is based at Colindale Avenue, London, NW9 5HT.

Responsibilities section:

In collaboration with the divisional Quality and Compliance teams to become familiar with the area of work for which he/she is Regulatory Compliance Manager and be familiar with relevant statutory requirements, including awareness of regulatory acts, clinical governance, risk management, Caldicott and quality policies and procedures of High Containment Microbiology. As the Regulatory Compliance Manager your main responsibilities will include:

Regulatory Compliance

  • To ensure that High Containment Microbiology complies with IVD regulations, relevant ISO and other accreditation standards in collaboration with the IVD/DDEU Programme Core Team, divisional and UKHSA Quality teams, and other senior staff.
  • To take part in the continuous improvement in service delivery and quality compliance within all areas of High Containment Microbiology, using modern methods in quality improvement, ensuring the highest standards of quality and process control.
  • To take part in the identification and implementation of ongoing quality improvements, ensure that paper and electronic records are managed in accordance with relevant policies and legal requirements and also ensure that appropriate standard operating procedures (SOPs) are developed and implemented.
  • To manage relevant technical, administrative and support staff in accordance with UKHSA policies and procedures, including:
  • To assist in the recruitment and selection of staff
  • To ensure that relevant UKHSA health and safety policies are implemented in collaboration with the safety team.

It is important through your application and Statement of Suitability of 750 words that you give evidence and examples of proven experience of each of the following criteria:

Essential

  • Science degree or equivalent experience in microbiology or a related pathology discipline
  • Postgraduate scientific qualification or demonstrable equivalent experiential learning gained in a medical laboratory environment
  • Evidence of continuing professional development and willingness to continue the learning process through academic or practical experience
  • Substantial laboratory experience working in an accredited medical laboratory
  • Experience in applying a range of standards, regulations and guidelines applicable to clinical laboratories
  • Understanding of IVD governance principles and procedures
  • Understanding and experience of change management
  • Experience of managing projects
  • Sound knowledge of common IT programmes, including Q Pulse and excellent keyboard and IT skills.
  • Excellent verbal and written communication, data analysis and statistical skills
  • Experience of attending management meetings and presenting information to management
  • Ability to work on own initiative and as part of a team
  • Excellent interpersonal, negotiating, and organisational skills, self–motivated, analytical and adaptable

Selection process details

STAGE 1 – APPLICATION & SIFT:

You will be required to complete an application form. This will be assessed in line with the advertised essential criteria – please do provide evidence of how you meet this.

If you are successful at this stage, you will progress to an interview.

STAGE 2 – INTERVIEW

This competition will involve an interview by video.

As part of the process, candidates will be invited to interview which will involve an in–depth discussion of your previous experience and professional competence in relation to the criteria set out in the Person Specification.

As part of the process, candidates will be invited to interview which will involve an in–depth discussion of your previous experience and professional competence in relation to the criteria set out in the Person Specification. Candidates will also be asked to participate in a session where they will be required to prepare and deliver a 10 minute presentation to the panel. This will be followed by a question–and–answer segment. The presentation will be designed to assess each candidate's experience in line with the requirements of the role. Full details will be provided prior to the interview.

Expected Timeline:

Advert close: 23:55hrs on 11th June 2023 – unfortunately, late applications will not be considered. Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Interviews: W/C 26th June 2023

Please note these dates could be subject to change.

For more details and full Job Description, please click apply.

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