R&D Project Manager - Peptide Development H/F

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

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

You will be involved in product development activities and will 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, including defining material specifications, conducting design verification testing, and supporting shelf-life and packaging integrity studies.
• Contribute to the preparation of Device Descriptions, Design & Development Plans, User Requirements Specifications (URS) and technical reports, in accordance with ISO 13485 and FDA QSR requirements.
• Collaborate 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.
• Participate in the evaluation of materials and processes, including liaising with suppliers regarding formulation and packaging components.
• Contribute to risk management activities in accordance with ISO 14971, ensuring consistency and traceability between design activities, 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.
• Support the preparation of regulatory submission dossiers by providing the required technical documentation and supporting rationales.
• Participate in test planning, data analysis and interpretation of results related to product and packaging performance.

Your contribution will be essential to the overall mission of developing innovative medical solutions that improve patient care and outcomes.

Profil

We are looking for an Engineer/Scientist specialized in medical device development, holding a Master’s degree (Bac+5) in Biochemistry, Chemistry, Chemical Engineering, Materials Science, Biomedical Engineering, Packaging Engineering, or a related technical field.

The successful candidate will have 3 to 5 years of experience in medical device development, ideally within the dental, pharmaceutical or Life Sciences sectors, with a strong understanding of Design Control, technical writing and regulatory documentation, including DHF, DMR and DDP, as well as ISO 13485, ISO 14971, EU MDR and FDA 21 CFR 820 requirements.

Your background in biochemistry, chemistry and/or materials science will support peptide formulation expertise and compatibility studies, while your experience with packaging development will be essential to drive packaging design, validation and stability activities.

Experience in packaging design and validation, including material compatibility, sealing and stability testing, as well as a strong understanding of chemical and material properties, particularly biomaterials, polymers or peptide-based systems, is highly desirable.

Proficiency in Microsoft Office and familiarity with QMS/PLM systems are considered a plus.

Above all, we are looking for a rigorous, organized, proactive and autonomous professional, capable of working cross-functionally with a wide range of stakeholders. The ideal candidate should also be creative, curious, solution-oriented and bold, with a genuine ability to take initiative, challenge existing approaches and take calculated risks in an innovative environment.

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