Design Control And Risk Management Compliance Engineer
Cambridge, ENG, GB, United Kingdom
Job Description
Job Title:
Professional - Design Control and Risk Management Compliance EngineerLocation:
Cambridge, UK (Onsite/Hybrid)Duration:
12 months (37 hrs/week)Job Overview
Client's Biotherapeutics Pharmaceutical R&D team in Cambridge is seeking a
Design Control & Risk Management Compliance Engineer
to provide expertise inmedical device and combination product development
throughout the product lifecycle. The role ensures compliance with global quality/regulatory standards and supports clinical and commercial programs.Key Responsibilities
Lead
design control and risk management
for medical device/combination products. Author, review, and maintain design and risk documentation forclinical trials and regulatory submissions
. Supportdesign validation, usability, and risk assessments
. Work closely withdevice development teams, QA, regulatory, manufacturing sites, and external CMOs
. Contribute tointernal and external audits
of QMS.Required Background
Education:
BSc/MSc in Science or Engineering (Chemistry, Biology, Biomedical, Mechanical, Chemical, Materials).
Experience:
5+ years in
pharmaceutical device/combination products
. Strong knowledge ofISO 13485, ISO 14971, 21 CFR 820/4, EU MDR
. Hands-on expertise indesign control & risk management
. Familiarity withHuman Factors/Usability Engineering
. Understanding ofdevice assembly & manufacturing
.Skills:
Knowledge of EN 62366, EN 60601, EN 62304. GMP experience. Strong communication, collaboration, and documentation skills.
Job Type: Fixed term contract
Contract length: 12 months
Pay: 20.25-23.00 per hour
Expected hours: 37 per week
Work Location: In person
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Job Detail
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Job IdJD3638524
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationCambridge, ENG, GB, United Kingdom
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EducationNot mentioned