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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in risk management for medical devices and drug-device combination products, utilizing ISO14971 methodologies and leading cross-functional teams in risk assessments and decision-making processes. Strong analytical skills and effective communication abilities are essential for presenting complex risk issues to diverse stakeholders.
Highest-signal resume keywords
Risk ManagementISO14971 MethodologiesFailure Modes and Effects Analysis (FMEA)Cross-Functional Team LeadershipRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Risk AssessmentFailure Mode AnalysisHazard AssessmentRoot Cause InvestigationRisk Framework DesignData AnalysisRisk TrackingDocumentation ManagementQuality AssuranceReliability Engineering
Soft Skills
Clear CommunicationCoachingProblem-SolvingCollaborationPresentation Skills
Tools & Technologies
Digital Tools for Data AnalysisRisk Management SoftwareReporting Tools
Certifications & Qualifications
IRCACQE
Industry Keywords
Medical DevicesPharmaceuticalsGMPRegulated ManufacturingLife Sciences
About the role
Key responsibilities & impact- Serve as PDDS risk owner for designated device and combination product programmes, owning the Risk Management File and leading risk assessments.
- Design and maintain risk frameworks, tools and documentation to support consistent decision making.
- Run failure mode analysis, hazard assessments and root cause investigations with cross-functional teams.
- Lead cross-functional risk assessment workshops with Human Factors, Device Engineering, Formulation, Primary Packaging, Clinical, Safety, Regulatory, Quality and Manufacturing stakeholders.
- Identify hazards, hazardous situations, foreseeable misuse and associated harms.
- Support regulatory and audit readiness by preparing risk rationales and evidence for inspections.
- Coach and uplift site and project teams in risk thinking, tools and best practice.
- Establish, execute and continuously improve risk management for medical devices and drug-device combination products across PDDS.
Requirements
What you’ll need- Degree in Engineering, Science, Risk Management, or a related discipline, or equivalent experience.
- Strong experience in risk management or reliability roles within regulated manufacturing or life sciences.
- Practical experience with ISO14971 risk methodologies such as Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA) or similar.
- Experience working alongside engineering, quality, operations and procurement teams.
- Clear written and verbal communication skills, able to present complex issues simply to different audiences.
- Preferred: Experience in pharmaceutical or medical device environments with understanding of GMP expectations.
- Preferred: Formal risk or quality qualifications, such as IRCA or CQE, or equivalent training.
- Preferred: Familiarity with regulatory risk expectations and inspection interactions.
- Preferred: Comfort using digital tools for data analysis, risk tracking and reporting.
- Preferred: Experience coaching teams and embedding risk-led cultures across sites.
- Preferred: Strong analytical and structured problem-solving skills, with ability to synthesise technical and clinical information into clear risk assessments.
Benefits
Comp & perks- Access to learning, mentorship and stretch opportunities
- Agile working culture and flexibility opportunities
- Reasonable adjustments to support application or interview
- Equal opportunity employment