R&D and Regulatory Project Manager at Beez Biotech

Company Overview
Beez Biotech is an innovative start-up in the field of fertility, specializing in the development of high value-added medical devices, looking for an employee to join a dynamic environment at an early stage of development.

Main Responsibilities
The R&D project manager will be responsible for managing the R&D project from prototype to commercialization. He/she will help finalize the design of the device, then implement the quality system and draft 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.
• Conduct regulatory watch on changes to requirements relevant to medical devices (MDR 2017/745, ISO 13485, FDA,
  etc.).
• 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 the 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.
• First experience in regulatory affairs, quality, or internship/apprenticeship preferably in the field of medical devices. (2-3 years)
• Rigor, analytical and synthesis skills, organization, curiosity, autonomy, and team spirit.
• Good writing and communication skills.
• Professional English proficiency is required (C1 level TOFEL/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 benefit

Contact

Beez Biotech – Rue Pierre Joseph Colin 35000 Rennes
Email : office@beezbiotech.com
Tél : +33 2 99 51 04 87