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About the Role
We are seeking an experienced Medical Device Quality Specialist Consultant to support the development and life-cycle management of Medical Devices (including SaMD) and combination products. You will play a pivotal role in helping clients navigate regulatory complexity, embed robust quality systems, and ensure product safety, compliance, and performance from early development through to post-market.
Responsibilities
- Apply quality and regulatory expertise across client engagements.
- Work within and advise on Quality Management Systems compliant with ISO 13485 and QMSR.
- Author, review, and maintain Design History Files, risk management files, technical documentation, and change control records.
- Support supplier qualification, audits, and gap assessments.
- Advise on medical device quality and regulatory requirements for US/EU market access.
- Provide specialized support for Software as a Medical Device (SaMD), including SDLC and compliance with IEC 62304 and IEC 82304.
- Interpret and apply global combination product regulations.
- Support the preparation of regulatory submissions, technical dossiers, and responses to authorities.
- Lead and support technology transfer activities.
- Contribute to process validation, equipment qualification, and technical knowledge transfer.
- Lead risk management activities in line with ISO 14971.
- Support post-market surveillance, vigilance, and complaints investigations.
- Work as part of, or lead, cross-functional project teams, managing quality deliverables and tracking actions.
Requirements
- Prior management consultancy experience is highly desirable.
- Significant experience (typically 8+ years) within the medical device industry.
- Strong, hands-on knowledge of quality systems and regulatory frameworks (ISO 13485, 21 CFR Part 4, FDA, UK MDR, EU MDR).
- Proven experience authoring and maintaining quality and technical documentation in regulated environments.
- A well-developed understanding of risk management (ISO 14971) and exposure to human factors/usability engineering.
- Experience with supplier quality, audits, CAPA, and document control.
- Excellent communication, organizational, and project management skills.
- Confidence to work with diverse stakeholders.
- Must meet residency requirements for UK security clearance (British citizen or resident in the UK for the past 5 years).
Skills
- Medical Device Quality Specialist
- SaMD (Software as a Medical Device)
- Combination Products
- Quality Management Systems (ISO 13485, QMSR)
- Design History Files
- Risk Management (ISO 14971)
- Technical Documentation
- Change Control
- Supplier Qualification
- Audits
- Gap Assessments
- US/EU Market Access
- Software Development Lifecycle (SDLC)
- IEC 62304
- IEC 82304
- Drug-device combination products
- Biologic-device combination products
- Advanced therapy-device combination products
- CCIT (Container Closure Integrity Testing)
- Stability/compatibility studies
- Regulatory Submissions
- Technical Dossiers
- Technology Transfer
- Process Validation
- Equipment Qualification
- Post-market Surveillance
- Vigilance
- Complaints Investigations
- CAPA
- Human Factors/Usability Engineering
- Document Control
- Project Management
Location
- London Victoria
- Melbourn (SG8)
Work Type
- Hybrid working
- On client site
Experience Level
- Experienced
- 8+ years
Education Level
- Degree in life sciences, pharmacy, engineering, or a related discipline
Benefits
- Health and lifestyle perks accompanying private healthcare
- 25 days annual leave (plus a bonus half day on Christmas Eve)
- Opportunity to buy 5 additional days annual leave
- Generous company pension scheme
- Opportunity to get involved with community and charity-based initiatives
- Annual performance-based bonus
- PA share ownership
- Tax efficient benefits (cycle to work, give as you earn)
About the Company
- We believe in the power of ingenuity to build a positive human future.
- Our teams of interdisciplinary experts combine innovative thinking and breakthrough technologies to progress further, faster.
- Our clients adapt and transform, and together we achieve enduring results.
- We are over 4,000 strategists, innovators, designers, consultants, digital experts, scientists, engineers, and technologists.
- We have deep expertise in consumer and manufacturing, defence and security, energy and utilities, financial services, government and public services, health and life sciences, and transport.
- Our teams operate globally from offices across the UK, Ireland, US, Nordics, and Netherlands.
- PA. Bringing Ingenuity to Life.
Equal Opportunity
- We are committed to advancing equality.
- We recruit, retain, reward and develop our people based solely on their abilities and contributions and without reference to their age, background, disability, genetic information, parental or family status, religion or belief, race, ethnicity, nationality, sex, sexual orientation, gender identity (or expression), political belief, veteran status, or any other range of human difference brought about by identity and experience.
- We welcome applications from underrepresented groups.
- Should you need any adjustments or accommodations to the recruitment process, at either application or interview, please contact us on [email protected]