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Head of QARA
5 months ago
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
