Senior Manager, Combination Products – Technical Leader

Keenova Therapeutics plc; Dublin; Hybrid; EUR 75,000 - 125,000; Full time

Job summary

Keenova Therapeutics plc in Dublin, Ireland, is seeking a Senior Manager, Combination Products. You will act as the principal technical expert for combination-product assets and provide leadership across design controls, product quality, engineering, risk management, and lifecycle support.

The role requires deep regulatory and technical knowledge, ability to influence strategy across cross-functional teams, and collaboration with external partners.

Qualifications

• Bachelor's degree in engineering, life sciences, or quality required.
• Minimum 8 years in medical devices, combination products, or regulated healthcare.
• Experience with design controls, risk management and product quality.
• Knowledge of FDA, EU, ISO 13485 requirements.
• Ability to influence technical strategy without direct authority.
• Strong written and verbal communication for senior stakeholders.

Responsibilities

• Provide technical leadership for design controls, risk management, and product quality.
• Lead design-history documentation and change control processes.
• Oversee verification/validation, risk assessments, and engineering evaluations.
• Support investigations, CAPAs, and supplier issues.
• Assist regulatory submissions, inspections, and agency interactions.
• Mentor cross-functional teams and plan resource needs.
• Develop technical due diligence assessments for future opportunities.

Skills

Design controls

Risk management

Product quality

Engineering leadership

Regulatory support

Cross-functional collab

Education

Bachelor's degree in engineering or life sciences

Job description

Keenova Therapeutics plc in Dublin, Ireland, is seeking a Senior Manager, Combination Products. You will act as the principal technical expert for combination-product assets and provide leadership across design controls, product quality, engineering, risk management, and lifecycle support.

The role requires deep regulatory and technical knowledge, ability to influence strategy across cross-functional teams, and collaboration with external partners.