We are currently looking for a Medical Device Lead to join a leading pharmaceutical company based on a hybrid basis in the Walloon Region, Belgium. As the Medical Device Lead, you will be responsible for leading the design, development, industrialisation, and lifecycle management of drug delivery systems, ensuring compliance with medical device regulations and Good Manufacturing Practices while providing technical leadership across cross-functional programs.
This is a two year mission with potential extension and the rate is between 640-720€ per day.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Medical Device Lead will be varied however the key duties and responsibilities are as follows:
* As the Medical Device Lead, you will lead technical activities relating to the development, industrialisation, lifecycle management, and maintenance of drug delivery systems, ensuring projects are delivered in line with quality, regulatory, and business objectives.
* As the Medical Device Lead, you will coordinate and provide technical leadership to program team members, internal stakeholders, and external partners, driving project management activities and strategic decision-making across medical device programs.
* As the Medical Device Lead, you will ensure compliance with the medical device Quality Management System, support risk management activities, and oversee the protection of intellectual property arising from development programs.
* As the Medical Device Lead, you will lead and provide oversight for design verification, design validation, process validation, commercial launch planning, and regulatory submission activities for combination products and medical devices.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Medical Device Lead we are looking to identify the following on your profile and past history:
* Relevant degree in engineering, biomedical engineering, or a related scientific or technical discipline.
* Proven industry experience leading medical device or combination product development activities within the pharmaceutical, biologics, or medical device sectors.
* A strong working knowledge and practical experience with ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, MDR requirements, and medical device lifecycle management within regulated environments.
Key Words: Medical Device Lead / Medical Device Manager / drug delivery systems / pharmaceutical / biologics / medical devices / GMP compliance / Quality Management System / ISO13485 / lifecycle management / regulatory submissions / industrialisation / Combination Products / Pharma / Life Sciences / technical leadership / design control / MDR / risk management
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.