Company

EngineeringSee more

addressAddressBarnsley, South Yorkshire
type Form of workPermanent
salary Salary£ 65000 - £ 80000 / Year
CategoryAdvertising & Marketing

Job description

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.

  • Implement effective risk management strategies.

  • 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.

Refer code: 3360845. Engineering - The previous day - 2024-05-18 07:34

Engineering

Barnsley, South Yorkshire
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