Medical Device Quality Specialist Consultant

Company description

Global Innovation and Technology Centre Back Lane, Melbourn SG8 6DP
, GB

Full-time

We believe in the power of ingenuity to build a positive human future.

As strategies, technologies, and innovation collide, we create opportunity from complexity.

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. And 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.

• 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.

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

• 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 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.

• 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…