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Recruitment Consultant - Connecting top talent with leading companies across Manufacturing and Engineering in the UK, European and US markets
Design Control & Risk Management Compliance Engineer
Location: Cambridge, UK
Hours: 37 hours per week
Contract: 12-month fixed term
Industry: Biopharma / Medical Devices / Combination Products
An exciting opportunity is available for a skilled Design Control & Risk Management Compliance Engineer to join a dynamic and collaborative team working on innovative drug-device combination products. This role offers the chance to contribute at a critical stage in the product lifecycle, ensuring quality and regulatory compliance from design through to commercial launch.
As a subject matter expert, you’ll lead design control and risk management processes while collaborating with cross-functional teams and external partners. Your expertise will help ensure products are developed in line with global regulatory standards and meet the highest quality and safety expectations.
Key Responsibilities
* Lead and manage design control and risk management activities across the full product lifecycle.
* Generate, maintain, and approve design control and risk documentation to support clinical and commercial activities.
* Ensure compliance with relevant internal policies and external regulations (ISO 13485, ISO 14971, 21 CFR 820/4, EU MDR).
* Work closely with external design firms, contract manufacturers, and internal development teams.
* Contribute to regulatory submission data and support internal and external audits.
* Drug product and device development teams (including engineers, analysts, packaging specialists, and SMEs)
* Quality Assurance and Regulatory Affairs teams
* External designers and Contract Manufacturing Organizations (CMOs)
* Manufacturing and post-launch teams
Required Qualifications and Experience
* BSc or MSc in a science or engineering discipline (e.g., Biomedical, Mechanical, Materials, Chemical, Chemistry, Biology)
* Minimum of 5 years of experience in medical device or combination product development
* Hands-on experience with design control and risk management practices
* Proven track record of working within ISO 13485, ISO 14971, 21 CFR 820/4, and EU MDR environments
* Familiarity with human factors engineering and usability testing
* Understanding of device assembly and manufacturing processes
Technical Skills and Competencies
* Knowledge of additional standards such as ISO 9001, EN 60601, EN 62304, and EN 62366 is desirable
* Strong attention to detail and technical accuracy
* Ability to work independently and manage multiple priorities
* Strong communication and documentation skills
* Proficiency in standard office and documentation tools
* Knowledge of Good Manufacturing Practices (GMP)
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Engineering and Design
* Industries
Medical Equipment Manufacturing
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