Freelance Device Program Lead

Planet Pharma; Waterloo; Hybrid; EUR 90,000 - 140,000; Full time

Job summary

Planet Pharma in Belgium is seeking a seasoned Device Program Lead to drive the development and delivery of drug-device combination products across a diverse portfolio. You will coordinate across engineering, quality, regulatory and manufacturing in a global, collaborative setting to ensure programs are delivered on time, within budget and in line with regulatory expectations.

You will lead programs from concept through commercialization, guide risk management and design control activities,

Qualifications

• Proven experience leading medical device, drug delivery or combination product development programs.
• Strong understanding of medical device product development processes and design control requirements.
• Experience working within highly regulated healthcare environments.
• Knowledge of ISO 13485 and ISO 14971 regulatory standards.

Responsibilities

• Lead end-to-end device development programs from concept through launch and lifecycle management.
• Drive program strategy, planning, execution and governance across multiple stakeholders and external partners.
• Coordinate multidisciplinary teams spanning engineering, manufacturing, quality, regulatory affairs and supply chain functions.
• Manage technical deliverables, timelines, budgets and resources to ensure successful outcomes.
• Support design control activities and ensure documentation is maintained throughout the product lifecycle.
• Provide technical leadership during development, scale-up and commercialization phases.

Skills

Medical device development

Project management

Cross-functional leadership

Regulatory knowledge

ISO 13485 knowledge

Lean Six Sigma

Job description

Location: Belgium, Waterloo Area, 2-3 days onsite Hybrid

Start: ASAP

FTE: 1.0 FTE, 40 hours per week

We are supporting a global healthcare innovator in the search for an experienced Device Program Lead to drive the development and delivery of complex drug-device combination products and drug delivery technologies across a diverse product portfolio. This is an excellent opportunity for a senior medical device professional who thrives in cross-functional environments and enjoys leading programs from concept through commercialisation and ongoing product evolution.

You will act as the central point of coordination across technical, quality, regulatory and manufacturing functions, ensuring programs are delivered on time, within budget and in line with global regulatory requirements. Working within a highly collaborative international environment, you will play a key role in bringing innovative patient-centric drug delivery solutions to market.

Key Responsibilities

• Lead end-to-end device development programs, from early-stage concept and feasibility through verification, validation, launch and lifecycle management.
• Drive program strategy, planning, execution and governance across multiple stakeholders and external partners.
• Coordinate multidisciplinary teams spanning engineering, manufacturing, quality, regulatory affairs and supply chain functions.
• Manage technical deliverables, timelines, budgets and resource requirements to ensure successful program outcomes.
• Support design control activities and ensure appropriate documentation is maintained throughout the product lifecycle.
• Provide technical leadership during development, scale-up and commercialisation phases.
• Drive risk management activities and support effective issue resolution across device programs.
• Collaborate with external suppliers, technology providers and manufacturing partners to ensure successful delivery of project objectives.
• Support continuous improvement initiatives and identify opportunities to enhance device performance, usability and patient experience.
• Contribute to regulatory submissions, product changes and post-market activities where required.
• Ensure development activities are aligned with applicable quality and regulatory standards.

What You Bring

• Proven experience leading medical device, drug delivery or combination product development programs.
• Strong understanding of medical device product development processes and design control requirements.
• Experience working within highly regulated healthcare, pharmaceutical, biotechnology or medical device environments.
• Knowledge of relevant regulations and standards including ISO 13485, ISO 14971 and global medical device requirements.
• Experience managing external development partners, suppliers and manufacturing organisations.
• Strong project and stakeholder management skills with the ability to influence across matrix organisations.
• Demonstrated ability to balance technical, commercial and operational priorities.
• Excellent communication and leadership skills with experience working across international teams.
• Track record of delivering complex technical projects within agreed timelines and budgets.
• Lean, Six Sigma and/or Project Management certifications would be advantageous.
• Experience within drug delivery systems, injectable devices, connected devices or combination products would be highly beneficial.

Why This Role

• Lead innovative device and combination product programs with global impact.
• Work within a forward-thinking organisation focused on improving patient outcomes.
• Collaborate with leading experts across engineering, manufacturing, quality and regulatory disciplines.
• High-visibility position with significant influence on product strategy and delivery.
• Opportunity to work on cutting-edge drug delivery technologies and future product platforms.
• Flexible hybrid working environment.
• Long-term freelance opportunity with strong extension potential.

Planet Pharma

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.