Medical Device Quality & Regulatory Consultant

PA Consulting; West of England; Híbrido; GBP 75.000 - 115.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health & lifestyle perks

25 days annual leave + half day on 24/

Generous pension

PA share ownership

Annual bonus

Tax efficient benefits

Community initiatives

Descripción de la vacante

PA Consulting seeks an experienced Medical Device Quality Specialist Consultant to support the development and lifecycle management of medical devices and combination products. You will help clients navigate regulatory complexity, embed quality systems, and ensure safety and compliance from development to post‑market.

The role emphasizes high‑level quality leadership, cross‑functional teamwork, and consulting delivery across global life sciences projects, with hybrid working in the UK.

Formación

• Degree in life sciences, pharmacy, engineering or related discipline.
• 8+ years of experience in the medical device industry.
• Strong knowledge of quality systems and regulatory frameworks (ISO 13485, 21 CFR Part 4, FDA, UK MDR, EU MDR).
• Proven ability to author and maintain quality and technical documentation.

Responsabilidades

• Provide quality assurance and regulatory guidance across client engagements.
• Advise on medical device quality, regulatory requirements and technical documentation for market access.
• Develop regulatory strategies and submissions for global markets.
• Lead technology transfer, lifecycle management, validation and qualification activities.
• Manage risk, post‑market surveillance and CAPA in regulated environments.

Conocimientos

Quality management

Regulatory affairs

Risk management

Documentation

Supplier quality

Project management

Communication

Educación

Life sciences/Engineering degree

Descripción del empleo

PA Consulting seeks an experienced Medical Device Quality Specialist Consultant to support the development and lifecycle management of medical devices and combination products. You will help clients navigate regulatory complexity, embed quality systems, and ensure safety and compliance from development to post‑market.

The role emphasizes high‑level quality leadership, cross‑functional teamwork, and consulting delivery across global life sciences projects, with hybrid working in the UK.