Medical Device Quality & Regulatory Consultant

PA Consulting; Royston; Ibrido; GBP 90.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health and lifestyle perks

25 days annual leave

Generous pension

Annual bonus

PA share ownership

Descrizione del lavoro

PA Consulting, based in the UK, seeks an experienced Medical Device Quality Specialist Consultant to support quality systems, regulatory compliance, and lifecycle management of medical devices and combination products. You will work with multi-disciplinary teams across ISO 13485, 21 CFR Part 4, FDA, UK MDR and EU MDR requirements.

You’ll lead regulatory submissions, risk management (ISO 14971), supplier quality, CAPA, and post-market activities, contributing to development from early stages

Competenze

• Deep knowledge of quality systems and regulatory frameworks (ISO 13485, 21 CFR Part 4, FDA, UK MDR, EU MDR)
• Strong experience authoring and maintaining quality and technical documentation in regulated environments
• Proven experience leading supplier quality, audits, CAPA and document control
• Excellent communication, organisational and project management skills

Mansioni

• Apply quality and regulatory expertise across diverse client engagements
• Provide regulatory and technical guidance for medical devices and SaMD
• Develop regulatory submissions, technical dossiers, and responses to authorities
• Lead technology transfer and lifecycle management activities
• Lead risk management and post-market surveillance activities
• Manage cross-functional project teams to deliver quality outcomes

Conoscenze

Quality systems knowledge

Regulatory compliance

Stakeholder management

Consulting mindset

Formazione

Degree in life sciences, pharmacy, or engineering

Descrizione del lavoro

PA Consulting, based in the UK, seeks an experienced Medical Device Quality Specialist Consultant to support quality systems, regulatory compliance, and lifecycle management of medical devices and combination products. You will work with multi-disciplinary teams across ISO 13485, 21 CFR Part 4, FDA, UK MDR and EU MDR requirements.

You’ll lead regulatory submissions, risk management (ISO 14971), supplier quality, CAPA, and post-market activities, contributing to development from early stages