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Form of work
SalaryWe 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.
