R&D Project Manager - Medical Device Packaging Development H/F

KARPOS RH is recruiting on behalf of one of its clients, an R&D center specialized in the development of innovative medical devices and technologies in the healthcare sector, a R&D Project Manager – Medical Device Packaging Development.

Reporting to the R&D department and under the responsibility of the Development Director, you will play a key role in the design, development and technical documentation of innovative medical devices in the oral healthcare sector.

You will contribute to product development activities and be responsible for managing and maintaining the technical documentation required as part of the Design Control process, while ensuring compliance with applicable international medical device regulations and standards, including ISO 13485, FDA 21 CFR 820 and the EU MDR.

Key Responsibilities :

• Develop, review and maintain Design Control documentation, including design requirements, design specifications and outputs, verification and validation reports, risk management files and Design History Files (DHF).
• Contribute to the development of medical devices and their packaging systems, including material specifications, design verification testing, packaging integrity testing and shelf-life studies.
• Support the preparation of Device Descriptions, Design & Development Plans, User Requirements Specifications (URS) and technical reports in accordance with ISO 13485 and FDA QSR requirements.
• Work closely with cross-functional teams, including R&D, Quality, Regulatory Affairs, Clinical and Operations, to ensure that design and development activities meet technical and regulatory requirements.
• Contribute to the evaluation of materials and manufacturing processes, including technical discussions with suppliers regarding formulation components and packaging materials.
• Participate in risk management activities in accordance with ISO 14971, ensuring consistency and traceability between design inputs, verification activities and clinical performance.
• Prepare and maintain documentation related to Change Control, Corrective and Preventive Actions (CAPA) and Design Reviews.
• Contribute to the continuous improvement of Design Control processes and associated documentation templates and practices.
• Support the preparation of regulatory submission dossiers by providing the required technical documentation and supporting justifications.
• Participate in test planning, data analysis and interpretation of results related to product and packaging performance.
• Coordinate packaging development activities to ensure that packaging design, material selection, validation, stability and compatibility requirements are properly addressed throughout the product development lifecycle.

Your contribution will be essential to the development of innovative medical solutions designed to improve patient care and clinical outcomes.

Profil

You hold a Master’s degree (Bac+5) in Packaging Engineering, Materials Science, Biomedical Engineering, Chemistry, Chemical Engineering or a related technical field, and have a minimum of 3 to 5 years of experience in packaging development, ideally within the medical device, pharmaceutical or life sciences industries.

You have solid experience in packaging design and development, including material selection and specifications, design validation, packaging integrity and seal testing, stability testing and shelf-life studies. Your packaging development expertise will be essential to drive and secure packaging design, validation and stability activities throughout the product development process.

A strong understanding of biomaterials, polymers and/or peptide-based systems is also required, enabling you to contribute to product development and assess material compatibility with components and formulations.

Your background in chemistry, biochemistry and/or materials science will support your understanding of formulation-related requirements and compatibility studies, while your hands-on experience in packaging development will be essential to drive packaging design, validation, stability and integrity activities.

You have a strong understanding of Design Control principles and medical device technical documentation, as well as the main applicable standards and regulations, including ISO 13485, ISO 14971, EU MDR and FDA 21 CFR 820.

Comfortable working in a multidisciplinary environment, you are able to collaborate effectively with R&D, Quality, Regulatory Affairs, Clinical and Operations teams, as well as suppliers and external laboratories.

Rigorous, organized and analytical, you are able to structure complex technical information and translate it into clear, accurate and compliant documentation. You are proactive, curious, autonomous and highly collaborative, with a strong focus on quality and excellence.

Proficiency in Microsoft Office and familiarity with document management systems, QMS and/or PLM tools are required.

Fluent/professional English is essential, as the position is conducted entirely in English on a daily basis.