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QA & Regulatory Affairs Director

QA & Regulatory Affairs Director

  • Location

    Suffolk

  • Industry:

    Business Operations

  • Contract Type:

    Permanent

  • Salary:

    £60k - 70k per year

  • Contact:

    Phil Watson

  • Contact phone:

    000

  • Job ref:

    PHW52

  • Job Published:

    9 days ago

SoCode is exclusively partnering with an independent healthcare business seeking to expand their senior management team. The organisation is working towards AIM listing and requires a career driven QA professional to oversee a team of 4. While they are aligned with the medical field, they are open to considering applicants that have worked in a similarly highly regulated sectors such as Automotive or Aerospace.

You will report directly to the board and be responsible for expanding the QA and QC function. The business is moving into new areas and the regulatory standards are high, you will be responsible for developing robust procedures and systems to ensure compliance. As the business grows further, so will you with a clear path to the board.

Core duties will include:

  • Ensure continued regulatory compliance of products.
  • Implement and manage robust QMS.
  • Maintenance of current regulatory product information to support product release for assigned commercial products
  • Coordinating planning, writing and reviewing company information for all regulatory compliance submissions
  • Participate and support as an active member of a multi-disciplinary management team to establish regulatory strategies
  • Coordinate the preparation of documents and publishing requests to support responses to regulatory agencies.  Manage timelines to ensure approvals are timely and development objectives are met.
  • Support continuous improvement opportunities
  • Ensure compliance with company policies, procedures and training expectations.
  • Support the writing and implementation of new procedures and processes in QA team

Essential criteria:

  • BSc/BA with a minimum of three years of regulatory experience
  • Solid understanding of quality management systems
  • Solid working knowledge of highly regulated manufacturing or distribution sector
  • Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.