Quality & Regulatory Affairs Specialist

Do you want to join a fast growing and energetic medtech company in a quality and regulatory role? Then this position will be interesting for you.

Quality & Regulatory Affairs Specialist

Your Responsibilities

As a Quality and Regulatory Affairs Specialist at Medartis, you will support the local UK team in ensuring compliance with regulatory requirements and maintaining the highest quality standards in alignment with the global processes. You will be responsible for managing regulatory submissions, supporting quality control processes, and ensuring that our products meet all applicable local standards.

Main tasks:

• Manage all aspects of the Medartis Ltd Quality Management System as a process owner (e.g. Internal audit, document control, CAPA) and as a coach for the process owners (e.g. Operation, HR, Sales) to support an efficient business growth.
• Guarantee the compliance of the QMS with all applicable requirements.
• Manage external audits and internal audits activities.
• Manage all UKRP activities and responsibilities.
• Define the quality policy and implement the quality objectives together with the General Manager.
• Take part to local business development projects and Global QMS projects.
• Perform activities such as complaint handling, NC-CAPA, Field Safety Corrective Action.
• Perform QM Trainings and maintain a high-Quality Awareness in the organisation.
• Assist Finance and other departments in the compliance of tender reporting and applications.
• Comply with Medartis Code of Conduct and all policies and procedures.
• Management of MHRA submissions, managing effective communication with MHRA and other regulatory bodies.
• Supporting new product registrations and providing information to the senior leadership team and global headquarters.
• Manage the relationships between MHRA and other regulatory bodies.
• Participate and provide input to product development initiatives, pricing, tenders etc.
• Manage Pre-market regulatory approval for all products.
  
  

Your Qualifications

• Bachelor's degree or similar education in a relevant field (e.g., Regulatory Affairs, Quality Assurance, Biomedical Engineering, or a related discipline).
• Minimum of 3-5 years of experience in quality and regulatory affairs within the medical device or pharmaceutical industry, with a focus on orthopaedic devices preferred.
• Strong understanding of UK and European medical device regulations and standards (e.g., MDR, ISO 13485).
• Excellent communication skills, both written and verbal, with the ability to collaborate with cross-functional teams and external stakeholders.
• Detail-oriented and analytical, with a strong commitment to maintaining high-quality standards.
• Proficiency in using quality management and regulatory compliance software/tools.