Exciting opportunity! Our client is looking a dynamic Quality & Compliance Manager to lead their small and very friendly team. This hybrid role is key in managing their business systems, maintaining UK Responsible Person status, and ensuring day-to-day compliance.
Job Type: Hybrid 2 days in/3 days out
Role Highlights:
- Manage inhouse ISO systems.
- Maintain UK Responsible Person (UKRP) status and manage supplier relationships.
- Submit regulatory filings for IVD medical devices and prepare technical files.
- Oversee product trials and regulatory inspections.
- Ensure marketing collateral compliance and liaise with Notified Bodies and Competent Authorities.
- Stay updated with regulatory changes and provide training on regulations.
- Produce monthly reports for the Quality Director and manage external audits.
- Support continuous improvement projects across various departments.
What we're looking for:
- Proven experience in managing ISO systems including ISO 13485, ISO 9001, ISO 1400. Any experience ISO 45001 would be advantageous, but can be trained if needed.
- Experience with regulatory filings and technical file preparation for medical devices.
- Strong communication skills and up-to-date knowledge of regulatory legislation.
- Experience in conducting external audits and continuous improvement projects.
Perks:
- Competitive salary and benefits package.
- Flexible hybrid working arrangement.
- Opportunities for professional development.
- Be part of a dynamic and supportive team in a growing sector.
Join the team in making a difference in the medical devices sector! This a critical role in the team and they are looking to book in interviews asap. I look forward to hearing from you.