Regulatory and Quality Improvement Manager

  • Location:

    London, England

  • Sector:

    Healthcare

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Job ref:

    JF/022_1602670217

  • Published:

    5 days ago

  • Duration:

    Permanent

  • Start date:

    ASAP

  • Client:

    Undisclosed Company

Position: Regulatory and Quality Improvement Manager

Duration: Perm

Location: London

Salary: Skillset Dependant

Key Accountabilities:

  • Preparation and coordination or review of documentation or dossiers.
  • Update and maintain existing Technical Documentation and ensuring regulatory compliance requirements are met to a high standard.
  • Prepare new documentation as necessary including but not limited to, writing the General Safety and Performance Requirements, Post Market Surveillance Plan, Risk monitoring, IFU etc.
  • Manage the transition from IVDD to IVDR for Software as a Medical Device (SAMD).
  • Be the regulatory authority on managing compliance upstream and downstream. For example, providing regulatory approval as part of product development (upstream) and regulatory reporting advice on post release issues (downstream).
  • Monitor the relevant regulatory landscape and communicate this effectively to the relevant stakeholders.
  • Interact and liaise directly with regulatory authorities and notified bodies.
  • Assisting with Scientific Advice procedures Knowledge and Experience:
  • Ensuring coherence to requirements within the Quality Management System.
  • Working closely with the Head of Quality Assurance to ensure compliance is always maintained.
  • Be able to perform some quality improvement duties such as audits and
  • Know and understand the meaning behind our virtues of Empathy, Integrity, Focus, Connection, Speed, Curiosity, Impact and embody them in all aspects of your role.

Essential Skills:

  • Demonstrable understanding of harmonised ISO standards
  • Expert knowledge of medical device regulations
  • Excellent people skills and ability to adapt to the needs of the organisation whilst maintaining compliance
  • Strong stakeholder management capability and proven ability to communicate effectively both face to face and in writing
  • Strong analytical and problem-solving skillsets
  • Proven ability to prepare comprehensive and actionable reports
  • Familiarity with clinical research and the NHS.
  • Proven expertise in planning and conducting audits and writing audit reports
  • Able to review and to write good technical documents.
  • Proven ability to apply industry standards in a pragmatic value-added way.
  • Strong ability to work with minimum supervision and also as part of a team
  • Good applied understanding of MS Office products and systems such as Jira, Confluence.

Academic or vocational qualifications and/or professional memberships:

  • Degree level qualification, or equivalent experience, in a medical devices sector or relevant discipline
  • Authority to be a regulatory representative - either through qualification or experience

Key Relationships:

External:

  • Regulators
  • Certifying bodies

Internal:

  • Varying levels of seniority, particularly in the clinical services

Due to high volumes, unfortunately we will only be able to applications we feel have the correct skillset.

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