Medical Device Quality Specialist Consultant

Pa Consulting; Watford; Hybrid; GBP 90,000 - 120,000; Full time

Benefits offered by this job

Private healthcare

25 days annual leave

Company pension

Community involvement

Annual bonus

PA share ownership

Tax efficient benefits

Job summary

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

You will apply quality and regulatory expertise across diverse client engagements, lead quality deliverables, and work with cross‑functional teams.

Qualifications

• Degree in life sciences, pharmacy, engineering or related discipline.
• Significant experience (typically 8+ years) in medical device industry.
• Strong 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.
• Good understanding of risk management (ISO 14971) and usability engineering.

Responsibilities

• Quality assurance and compliance across client engagements.
• Support regulatory submissions, technical dossiers and responses to authorities.
• Lead and support technology transfer across development to manufacturing.
• Contribute to risk management activities and post‑market surveillance.
• Collaborate with cross‑functional teams and manage quality deliverables.

Skills

Quality management

Regulatory compliance

Stakeholder management

Quality systems knowledge

Education

Life sciences/pharmacy/engineering degree

Tools

ISO 13485

21 CFR Part 4

FDA

UK MDR

EU MDR

IEC 62304

IEC 82304

Job description

• Hybrid working - our approach is to be in the office or on client site a minimum of 2 or 3 days per week. However, the actual time you spend and where you spend it will vary by role or assignment, including up to 5 days per week on a client site.
• This role can be based at either our London Victoria or Melbourn (SG8) office

Within our Life Sciences work, we support global organisations to design, develop and bring to market innovative products that improve patient outcomes. This includes complex combination products across pharmaceuticals, medical devices, biologics and advanced therapies.

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 (drug–device, biologic–device and advanced therapy–device).

You will play a pivotal role in helping our clients navigate regulatory complexity, embed robust quality systems, and ensure product safety, compliance and performance from early development through to post‑market. Working as part of multi‑disciplinary project teams, you will bring deep technical expertise alongside strong collaboration and stakeholder engagement skills.

What you’ll do

You’ll apply your quality and regulatory expertise across a broad range of client engagements, including:

Quality assurance and compliance

• Working within and advising on Quality Management Systems compliant with ISO 13485, and QMSR.
• Authoring, reviewing and maintaining Design History Files, risk management file, technical documentation and change control records, ensuring alignment and traceability across the product life cycle.
• Supporting supplier qualification, audits and gap assessments, ensuring compliance with global regulatory expectations.

Medical Device Expertise

• Medical Devices: Advising on medical device quality and regulatory requirements, including product design and development, risk management, and preparation of technical documentation to ensure US/EU market access and compliance.
• SaMD (Software as a Medical Device): Providing specialised support for Software as a Medical Device, including the implementation and oversight of the software development lifecycle (SDLC) and compliance with IEC 62304 and IEC 82304.
• Combination Products: Knowledge of drug–device or biologic–device combination products, including awareness of regulatory considerations, CCIT (Container Closure Integrity Testing), and stability/compatibility studies, is considered an advantage.

Regulatory and technical strategy

• Interpreting and applying evolving global combination product regulations, providing pragmatic guidance throughout development, technical transfer, commercialisation and post‑market phases.
• Supporting the preparation of regulatory submissions, technical dossiers and responses to questions from competent authorities and notified bodies.

Technology transfer and lifecycle management

• Leading and supporting technology transfer activities across development, scale‑up and commercial manufacturing environments.
• Contributing to process validation, equipment qualification and technical knowledge transfer, ensuring regulatory alignment throughout.

Risk and post‑market activities

• Leading risk management activities in line with ISO 14971, including hazard analysis, risk evaluation and mitigation strategies.
• Supporting post‑market surveillance, vigilance and complaints investigations, ensuring robust CAPA and documentation.
• Working as part of, or leading, cross‑functional project teams, managing quality deliverables, tracking actions and supporting timely decision‑making.

Qualifications

We’re looking for someone who combines deep technical expertise with a consulting mindset. You’ll ideally bring:

• Prior management consultancy experience is highly desirable
• A degree in life sciences, pharmacy, engineering, or a related discipline.
• Significant experience (typically 8+ years) within 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, organisational and project management skills, with the confidence to work with diverse stakeholders.

Please be aware that some of our UK roles at PA Consulting require a UK security clearance.

All PA people are required to undergo background checks and to achieve the Baseline Personnel Security Standard however, some UK roles also require higher levels of National Security Vetting, where applicants must have at least 5 years of continuous residency in the UK.

We therefore ask that you only apply if you meet the residency requirements (i.e. you are a British citizen or have been resident in the UK for the past 5 years), as this is the prerequisite for a security clearance. If you're unsure about your eligibility, we encourage you to review the UK Government’s guidance on security vetting before applying.

Additional Information

Life At PA encompasses our peoples' experience at PA. It's about how we enrich peoples’ working lives by giving them access to unique people and growth opportunities and purpose led meaningful work.

Our purpose guides how we work with our clients and our teams, and support our communities, to deliver insight and impact, solving the world’s most complex challenges. We're focused on building a workplace that values human difference and diverse mindsets, and a culture of inclusion and equality that unlocks the potential in our people so everyone can be their best self.

We are dedicated to supporting the physical, emotional, social and financial well‑being of our people. Check out some of our extensive benefits:

• Health and lifestyle perks accompanying private healthcare
• 25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
• 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)

We’re 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.

Adjustments or accommodations - Should you need any adjustments or accommodations to the recruitment process, at either application or interview, please contact us on [e-mail]

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Medical Device Quality Specialist Consultant Melbourn, HERTFORDSHIRE, United Kingdom