Regulatory Manager

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

Our client offers a range of benefits, including:

• Working for a stable company with strong ownership.
• Employee bonus scheme based on sales performance.
• A collaborative and supportive working environment.
• Hybrid working arrangement, with minimum 2 days working remotely.

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.

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