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Senior Manager, Combination Products
Mallinckrodt Pharmaceuticals. Serve as the principal technical expert for combination-product assets and provide technical leadership for design controls, engineering, product quality, risk management, and lifecycle support activities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in design controls, risk management, and product quality for combination products, with a strong focus on regulatory compliance and technical leadership. Capable of influencing cross-functional teams and managing complex technical evaluations and investigations.
Highest-signal resume keywords
Design ControlsRisk ManagementRegulatory SupportTechnical InvestigationsProduct Lifecycle Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
EngineeringProduct QualityTechnical AssessmentsVerification and ValidationDesign History DocumentationCAPAChange ManagementSupplier ControlsRisk AnalysisRegulatory Documentation
Soft Skills
Strong Communication SkillsMentoringCollaborationInfluencing StrategyProblem Solving
Industry Keywords
Combination ProductsMedical DevicesPharmaceutical ProductsRegulated EnvironmentFDA RequirementsISO 13485EU RegulationsQuality EventsManufacturing DeviationsTechnical Due Diligence
About the role
Key responsibilities & impact- Serve as the principal technical expert for combination-product assets and provide technical leadership for design controls, engineering, product quality, risk management, and lifecycle support activities
- Maintain technical oversight of design history documentation, design control processes, risk management activities, and associated compliance requirements
- Lead technical evaluations supporting product, component, supplier, manufacturing, and lifecycle changes
- Provide technical leadership for verification and validation activities, design-risk assessments, engineering evaluations, and product performance assessments
- Lead and support investigations related to product complaints, quality events, manufacturing deviations, supplier issues, and CAPAs
- Support regulatory submissions, inspections, audits, and agency interactions through technical assessments, justification documents, and regulatory responses
- Provide technical due diligence for future combination-product opportunities, including product design, manufacturability, technical risks, and lifecycle requirements
- Act as a key knowledge resource, mentoring and collaborating cross-functionally to influence technical strategy and decision-making
- Support resource plans, project cost estimates, business cases, and investment proposals for combination-product programs
- Report to the Associate Director, Combination Products; work with Quality, Regulatory Affairs, Supply Chain, Manufacturing, and external partners
Requirements
What you’ll need- Bachelor's degree in engineering, pharmaceutical sciences, life sciences, quality, or a related technical discipline required; advanced degree preferred
- Minimum 8 years of experience supporting medical devices, combination products, pharmaceutical products, or other regulated healthcare products
- Demonstrated experience in design controls, risk management, product quality, engineering, technical investigations, product lifecycle management, and regulatory support activities
- Strong working knowledge of combination-product regulatory requirements, including design controls, risk management, supplier controls, complaint handling, CAPA, change management, and applicable FDA, EU, Part 4, and ISO 13485 requirements
- Experience leading technical assessments supporting product, supplier, manufacturing, quality, and lifecycle decisions in a regulated environment
- Demonstrated ability to influence technical strategy and decision-making across cross-functional teams and external partners without direct authority
- Strong written and verbal communication skills, including preparation and review of technical assessments, investigation reports, risk analyses, regulatory documentation, and presentations to senior stakeholders
- Demonstrated ability to evaluate complex technical issues, apply sound scientific and engineering judgement, assess product and compliance risks, and provide technically robust recommendations