Device Program Lead

Il y a 1 semaine

Brabant Walloon Region, 00, Belgique Akkodis Temps plein


About the Company
Akkodis, is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC. Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics. The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines – Consulting, Solutions, Talents and Academy – to support clients in rethinking their product development and business processes, improve productivity, minimize time to market and shape a smarter and more sustainable tomorrow.
Akkodis is part of the Adecco Group. Our Webstite : www.akkodis.com

About the Role
We are looking for an experienced Device Program Lead to lead the development, industrialization, and lifecycle management of drug delivery systems within a pharmaceutical environment. The role combines technical leadership, medical device expertise, and project management. You will coordinate cross-functional teams and external partners while ensuring compliance with Medical Device regulations, Quality Management Systems, and GMP requirements. Responsibilities
- Lead the development, industrialization, lifecycle management, and maintenance of drug delivery systems.
- Coordinate and lead cross-functional teams involving internal stakeholders and external partners.
- Manage technical projects, including planning, resources, budgets, suppliers, and industrialization activities.
- Ensure compliance with Medical Device Quality Management Systems and applicable regulatory requirements.
- Support design verification, design validation, process validation, commercial launch preparation, and regulatory submissions.
- Create and maintain the Design History File (DHF) throughout the product lifecycle.
- Coordinate technical activities related to marketed medical devices, including lifecycle management and maintenance.
- Support the evaluation of new devices and technologies and contribute to the development of new device programs.
- Identify and manage technical risks and contribute to corrective and preventive actions. Qualifications
- Required Profile 8+ years of experience within the pharmaceutical, biologics, and/or medical device industry. Required Skills
- Strong knowledge of medical device development and regulatory requirements.
- Practical understanding of ISO 13485, ISO 14971, MDR, 21 CFR 820, 21 CFR 210/211, 21 CFR Part 4, and ICH Q9.
- Experience working with cross-functional and matrix teams.
- Strong project management, planning, and organizational skills.
- Ability to lead and influence internal stakeholders and external partners.
- Strong communication and negotiation skills.
- Ability to analyze technical information, assess risks, make decisions, and drive issue resolution.
- Operational GMP or Quality experience is considered a strong advantage.
- Green Belt and/or Project Management certification is an asset. Pay range and compensation package What we have to offer At Akkodis, we want to give you the right environment to develop your expertise and grow throughout your career. You can count on:
- A permanent contract
- An attractive compensation package, including 13.92 months of salary
- A company car or mobility budget, depending on your package
- A flexible cafeteria plan
- Hospitalization insurance
- Training and development opportunities to strengthen both your technical and professional skills
- A structured onboarding and regular follow-up, including career discussions and support from your managers
- Access to technical communities and experts to exchange knowledge and develop your expertise
- Referral and business bonuses when you contribute to growing our teams and business
- Opportunities to develop your career across different projects, technologies, and areas of expertise