QARA Manager

Position:

Quality & Regulatory Affairs (QARA) Professional

Overview:

An innovative MedTech start‑up is seeking an experienced Quality and Regulatory Affairs professional to lead and maintain compliance across ISO 13485, UK MDR, and EU MDR frameworks. The company is developing a novel sampling medical device to support early detection and management of cancer.

This is an opportunity to play a key role in a small, collaborative team, shaping the company’s quality and regulatory foundations while driving ISO certification and product readiness.

Key Responsibilities:

• Maintain and continuously improve the ISO 13485‑compliant QMS, driving successful certification.
• Prepare and implement QMS policies, procedures, and documentation.
• Lead internal and supplier audits, management reviews, and CAPA/continuous improvement initiatives.
• Manage technical documentation and DHFs in compliance with EU MDR and UK MDR.
• Oversee regulatory and quality compliance during clinical investigations and post‑market activities.
• Act as the Person Responsible for Regulatory Compliance (PRRC).
• Monitor regulatory changes and advise leadership on compliance implications.
• Serve as the main contact for Notified Bodies, auditors, and competent authorities.
• Support training and awareness of QARA processes across the organisation.

Requirements:

• Proven experience with medical devices (ideally Class I) under UK and EU regulatory frameworks.
• Strong working knowledge of ISO 13485, including implementation and audit experience.
• Familiarity with ISO 14971, ISO 14155, ISO 10993, and IEC 62366‑1.
• Experience managing clinical investigation documentation.
• Confident managing a QMS independently within a fast‑paced, start‑up environment.
• Excellent organisational, communication, and problem‑solving skills.

Why Join:

• Work at the forefront of health innovation and contribute to meaningful diagnostic advancements.
• Opportunity to influence QARA strategy in a high‑growth environment.
• Competitive package, professional growth, and involvement across multiple clinical programmes.

Seniority Level:

Associate

Employment Type:

Full‑time

Job Function:

Quality Assurance, Writing/Editing, and Project Management

Industries:

Medical Equipment Manufacturing

Contact:

Email: feroze.malik@gxpeople.com
Phone: 020 8135 6831