R&D Programme Lead – Medical Devices

OrganOx, Inc.; Oxford; On-site; GBP 90,000 - 120,000; Full time

Benefits offered by this job

Healthcare

Retirement plans

Job summary

OrganOx in Oxford is seeking an experienced R&D Programme Manager to lead end-to-end New Product Development across regulatory, quality, manufacturing readiness and commercial priorities.

You will drive governance, risk management and stakeholder alignment across R&D, Regulatory, Quality Assurance, Operations and Clinical teams, delivering complex medical device programmes.

This on-site role offers flexibility and an opportunity to shape organ preservation technology within a world-class team.

Qualifications

• Proven Project Management experience in Medical Devices, Pharmaceuticals or equivalent.
• Track record in managing medical device design and development projects within ISO 13485 and IEC 60601.
• Excellent communication and leadership skills, commercially aware with ability to negotiate with suppliers and cross-functional internal stakeholders.
• Ability to lead cross-functional project teams and manage budgets.
• Experience with regulatory affairs, quality systems and risk management.

Responsibilities

• Lead strategic New Product Development programmes from concept through development, verification, validation, regulatory approval, manufacturing transfer and product launch.
• Develop and maintain integrated programme plans covering all programme workstreams.
• Define programme objectives, success criteria, milestones and critical dependencies.
• Ensure programme activities remain aligned to organisational strategy and product roadmap.
• Drive programme execution through proactive leadership, coordination and decision-making.
• Establish / maintain programme governance structures, reviews and reporting mechanisms.
• Facilitate programme steering committees and executive review meetings.
• Uphold programme management standards and best practices.

Skills

Project Management

Medical Devices

Regulatory Knowledge

Stakeholder Leadership

Cross-functional Collaboration

Budget Management

Communication

Risk Management

Education

Engineering degree or science discipline

PM training (PMP/Agile/Prince2)

Tools

MS Project

Excel

Job description

OrganOx in Oxford is seeking an experienced R&D Programme Manager to lead end-to-end New Product Development across regulatory, quality, manufacturing readiness and commercial priorities.

You will drive governance, risk management and stakeholder alignment across R&D, Regulatory, Quality Assurance, Operations and Clinical teams, delivering complex medical device programmes.

This on-site role offers flexibility and an opportunity to shape organ preservation technology within a world-class team.