R&D and Regulatory Project Manager

Beez Biotech is an innovative start-up in the field of fertility, specialising in the development of high-value-added medical devices. We are looking for an employee to join a dynamic environment at the commercialisation phase of our innovative sperm selection technology. 

Main Responsibilities 

The R&D project manager will be responsible for managing the R&D project from prototype to commercialisation. He/she will be involved in designing the device in industrial settings, implementing the quality system, and drafting the technical file for CE marking (including the collection and analysis of pre-clinical data). To do this, he/she will be in direct contact with our regulatory affairs service provider (senior profile), the founders, partner laboratories (usage and efficacy testing), and technical service providers (toxicity testing).

Regulatory 

• Participate in the implementation and improvement of the Quality Management System (QMS), aiming to obtain and maintain ISO 13485 certification. 
• Help prepare, draft, and update technical files for CE/FDA marking and other regulatory approvals. 
• Provide operational support to meet regulatory requirements for R&D, Production, Quality, and Marketing teams. 
• Ensure proper archiving and document management of regulatory and quality files. 
• Support the management of non-conformities, complaints, and corrective/preventive action plans. 
• Help train and raise awareness among internal teams about quality and regulatory requirements. 

R&D Management Tasks  

• Manage the operational aspects of the R&D project relating to the medical device, monitor schedules, deliverables, and milestones in collaboration with team. 
•  Organize and conduct preclinical tests in the laboratory and in clinical settings. 
• Monitor documentation relating to development: test protocols, reports, risk analyses, change management, and prototype validation. 
• Participate in the preparation of funding or innovation grant applications. 
• Contribute to coordination between R&D, Quality, and Regulatory Affairs activities to ensure compliance from the development phase onwards. 
• Prepare regular progress reports on projects for the founders. Desired Profile 
• Scientific educational background (master’s degree to PhD): engineering, master’s, pharmacy, or equivalent in life sciences, biomedical, or quality. 
• Beginner-level experience in regulatory affairs, quality, or internship/apprenticeship, preferably in MDR/IVDR (2-3 years).  
• Rigour, analytical and synthesis skills, organisation, curiosity, autonomy, and team spirit. 
• Professional English proficiency is required (C1 level TOEFL/IELTS score). 
• Adaptability for a startup environment. 

Conditions 

• Long-term contract, immediate start. 
• Location: Rennes on site. 
• Supervised by a senior Regulatory/Quality expert with rapid growth potential. 
• Stimulating and versatile working environment, participation in cross-functional assignments and innovative projects. 

Benefits 

• Agile working environment, versatile tasks, accelerated skills development. 
• Friendly, start-up spirit. 
• Contribute to a project with a strong impact on health and quality of life.
•  Gross Salary 35-42k euros per year with 100% mobility and health insurance benefits.

Ideal Starting : 01/12/2025

For additional information, contact office@beezbiotech.com.