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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Device Project Management and Combination Product Development, with a strong focus on project leadership, strategic initiative implementation, and cross-functional collaboration. Proficient in managing resources, budgets, and timelines while ensuring compliance with quality standards and regulatory requirements.
Highest-signal resume keywords
Device Project ManagementCombination Product DevelopmentProject Management CertificationBiopharmaceutical Product DevelopmentCross-Functional Team Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project ManagementDesign ControlsProcess DevelopmentResource ManagementBudget ManagementTimeline ManagementQuality Standards ComplianceClinical Development PlanningTechnical PresentationStrategic Initiative Implementation
Soft Skills
PlanningCoordinationTeamworkCommunicationInterpersonal Relations
Certifications & Qualifications
Project Management Certification
Industry Keywords
Device DevelopmentRegulatory AffairsQuality AssuranceProcess EngineeringBiologics Product Development
About the role
Key responsibilities & impact- Lead the Device Project Management group
- Manage resources, budgets, talent, and employee development
- Ensure Combination Product programs meet timelines, quality, budget, project standards, company quality standards, and AstraZeneca’s strategy
- Define, communicate, and implement device project management strategy
- Interpret and apply Design Controls
- Facilitate planning, execution, and approval of Design Control Deliverables
- Develop and maintain processes, tools, and technology for leading a project portfolio
- Manage projects aligned with clinical and commercial development plans
- Introduce new approaches to project leadership and planning using available systems and resources
- Lead and implement strategic initiatives related to Device Project Management and Combination Product Development
- Collaborate with Device Team Leads, CMC Project Managers, and teams across Device Development, Quality, Regulatory Affairs, Drug Development, Process Engineering, Biologics Product Development, and AstraZeneca
- Present technical and non-technical materials to senior management, health authorities, auditors, and internal and external stakeholders
Requirements
What you’ll need- Bachelor's, Master's, or PhD in a relevant technical discipline such as Biomedical, Mechanical, or Chemical Engineering, or equivalent industry experience such as Device Development, Regulatory, Quality, or Process Engineering
- 10+ years of product development experience
- 5+ years of Project Management experience, with the majority focused on Combination Product Development
- 3+ years of experience leading a project management office
- Experience planning, managing, and executing functional and/or cross-functional aspects of device development in the context of combination products
- Working knowledge of biopharmaceutical product development
- Experience managing distributed resources across multiple sites and time zones
- Professional Project Management certification desired
- Advanced degree within the field desired
- High level of commitment, flexibility, and independence
- Strong planning, coordination, teamwork, communication, and interpersonal relations skills
Benefits
Comp & perks- Short-term incentive bonuses
- Equity-based awards for salaried roles
- Qualified retirement programs
- Paid time off, including vacation, holiday, and leaves
- Health coverage
- Dental coverage
- Vision coverage
- Flexible working arrangement balancing office attendance with individual flexibility