Manager, Combination Productions

Mallinckrodt Pharmaceuticals

. Provide technical support for stewardship, lifecycle management, and long-term support of combination-product assets .

Posted 11/2/2026full-timeDublin • IrelandMid-LevelSenior💰 €56,400 - €94,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in technical support for combination products, including lifecycle management, regulatory compliance, and risk assessment. Proven ability to collaborate with cross-functional teams and maintain critical product knowledge while ensuring product continuity and supplier oversight.

Highest-signal resume keywords

Technical Support For Combination ProductsProduct Lifecycle ManagementRegulatory Compliance (FDA, EU, ISO 13485)Risk Assessment And MitigationCross-Functional Team Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Technical Risk AssessmentLifecycle RoadmapsSupplier QualificationChange ManagementDesign ControlsComplaint HandlingCAPAManufacturing Change AssessmentObsolescence Risk ManagementProduct Impact Assessments

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationIndependent Evaluation Of Technical IssuesPrioritization Skills

Industry Keywords

Combination ProductsMedical DevicesPharmaceutical ProductsRegulated Healthcare ProductsSupplier GovernanceQuality EventsTechnical AgreementsManufacturing TransfersAlternate Sourcing InitiativesContinuity-Of-Supply Principles

About the role

Key responsibilities & impact

Provide technical support for stewardship, lifecycle management, and long-term support of combination-product assets
Maintain product technical strategies, lifecycle roadmaps, technical risk assessments, and product continuity plans
Lead technical assessment and implementation of product, component, supplier, manufacturing, packaging, and lifecycle changes
Establish and maintain technical relationships with external manufacturers, component suppliers, and development partners
Support supplier qualification, technical due diligence, performance reviews, technical agreements, and ongoing oversight of critical suppliers and manufacturing partners
Assess and mitigate product, supplier, manufacturing, continuity-of-supply, and obsolescence risks
Support technical investigations, product impact assessments, quality events, corrective actions, manufacturing transfers, alternate sourcing initiatives, and supplier-related changes
Partner with Quality, Regulatory Affairs, Supply Chain, Manufacturing, and Technical Operations to ensure lifecycle execution, product continuity, regulatory compliance, and maintenance of critical product knowledge
Report to the Associate Director, Combination Products as an individual contributor with no direct reports

Requirements

What you’ll need

Bachelor's degree in engineering, pharmaceutical sciences, life sciences, or a related technical discipline required
Minimum 5 years of experience supporting medical devices, combination products, pharmaceutical products, or other regulated healthcare products
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
Understanding of product lifecycle management, manufacturing change assessment, supplier governance, technical risk assessment, and continuity-of-supply principles
Experience working effectively in cross functional teams
Strong written and verbal communication skills
Demonstrated ability to independently evaluate technical issues, assess risks, prioritize activities, and support compliant product and lifecycle decisions

Benefits

Comp & perks

Hybrid working arrangement
Minimum three days per week on-site in Dublin
Travel to internal and external manufacturing organizations, partner sites, and other domestic or international locations as business needs dictate