Head of QARA

2 weeks ago


United Kingdom Adecco Full time

We are currently seeking a highly skilled and experienced QARA Manager to join our client's innovative organisation.

In this company, you will play a key role in ensuring regulatory compliance for our client's Class III Orthopaedic products. The successful candidate will have a strong background working with Notified Bodies, technical file remediation and creation, risk management, and global product submissions.

Responsibilities:

  • Collaborate with Notified Bodies to ensure compliance with regulatory requirements.
  • Lead the remediation and creation of tech files for existing and new products.
  • Manage global product submissions, with a focus on expanding into emerging markets.
  • Drive the development and maintenance of the Quality Management System (QMS).
  • Provide strategic guidance on working with Notified Bodies and developing an effective strategy for the Medical Device Regulation (MDR).
  • Take a hands-on approach in writing technical documentation and be willing to roll up your sleeves as needed.

Qualifications:

  • Extensive experience in Class III Orthopaedic regulatory affairs.
  • Strong knowledge of QMS, preferably with experience in Qpulse EQMS.
  • Strategic mindset with the ability to navigate the complex landscape of regulatory compliance.
  • Excellent written and verbal communication skills.
  • Proven experience managing and leading a team.

Our client offers a range of exciting benefits, including:

  • Working for a stable company with strong ownership.
  • Employee bonus scheme based on sales performance.
  • A collaborative and supportive working environment.

If you are a highly motivated and experienced QARA Manager looking for a new challenge, we would love to hear from you.

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