Senior Medical Device Quality Consultant (Hybrid)

Purchaseyourfreedom; Melbourn; Hybrid; GBP 110.000 - 190.000; Vollzeit

Benefits dieser Stelle

Health & lifestyle benefits

25 days annual leave

Company pension

Annual performance-based bonus

PA share ownership

Tax efficient benefits (cycle to work)

Zusammenfassung

PA Consulting is seeking 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 robust quality systems, and ensure product safety and compliance from development through post‑market.

Ideal candidates have 8+ years in the medical device field, consultancy experience, and strong knowledge of ISO 13485, 21 CFR Part 4, FDA, UK MDR and EU

Qualifikationen

• Degree in life sciences, pharmacy, engineering or related field.
• 8+ years of medical device industry experience.
• Strong knowledge of quality systems and regulatory frameworks (ISO 13485, FDA, UK MDR, EU MDR).
• Experience in risk management (ISO 14971) and post‑market activities.
• Consulting experience is highly desirable.

Aufgaben

• Provide quality and regulatory strategy across medical devices and combination products.
• Develop and maintain technical documentation and regulatory submissions.
• Lead risk management activities and CAPA programs.
• Support technology transfer, lifecycle management and post‑market surveillance.
• Collaborate with cross‑functional teams and client stakeholders.

Kenntnisse

Consulting experience

Medical device industry

Quality systems

Regulatory knowledge

ISO 13485

FDA compliance

UK MDR/EU MDR

Risk management ISO14971

CAPA & supplier quality

Stakeholder management

Communication

Ausbildung

Life sciences / pharmacy / engineering degree

Jobbeschreibung

PA Consulting is seeking 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 robust quality systems, and ensure product safety and compliance from development through post‑market.

Ideal candidates have 8+ years in the medical device field, consultancy experience, and strong knowledge of ISO 13485, 21 CFR Part 4, FDA, UK MDR and EU