Regulatory Affairs Specialist
Famille de fonction : Affaires réglementaires
Description du poste et des missions
As part of our continuous growth, we are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our dynamic team. In this role, you will drive the regulatory strategy, support product development, and ensure the efficient setup of manufacturing capabilities. You will identify regulatory requirements and oversee all regulatory processes throughout development and manufacturing, contributing to the marketability of the Lakhesys Benchtop Cell Factory™.
Location: Kremlin Bicêtre
Main Responsibilities:
1- Regulatory Strategy & Compliance
Lead the development and execution of regulatory strategies for product development and manufacturing build-up
Ensure all regulatory activities are aligned with industry standards and support the company’s long-term goals
Serve as the primary point of contact for regulatory bodies, ensuring compliance with applicable regulatory requirements for bioprocess manufacturing equipment, single-use consumables, and software
Develop and maintain the technical and regulatory files up to date
2- Support Product Development & Manufacturing Build-Up
Collaborate with product development teams to ensure regulatory requirements are integrated into the design and development process
Provide regulatory guidance for the build-up of manufacturing processes, ensuring adherence to relevant regulations and industry best practices
3- External Expert Engagement
Build and maintain strong relationships with external regulatory experts, consultants, and bodies to ensure ongoing compliance and to stay informed on evolving regulations
Engage with industry peers, forums, and conferences to enhance the company’s regulatory standing
Profil souhaité
Technical skills:
At least 5 -8 years of experience in regulatory affairs within the bioprocess manufacturing, medical equipments, medical devices, or diagnostics, with hands-on experience in preparing, writing and submitting regulatory filings and interactions with agencies such as FDA and EMA
Experience in the development and commercialization of regulated equipment, including experience with software integration and plastic consumables.
In-depth working knowledge of global regulatory requirements and industry standards (e.g., ISO 13485, FDA 21 CFR Part 820)
Ability to apply knowledge to equipment, consumable and software development (design, control, process validation) and authoring of design history and technical files.
Experience working with regulatory bodies and managing customer requests, audits, and compliance documentation.
Interpersonal and Leadership Skills:
Ability to build credibility and trust with external experts, competent authorities, and regulatory bodies
Exceptional communication and interpersonal skills, with the ability to work within a team and as an individual contributor in a fast-paced, changing environment
Proficiency in regulatory software and tools used for compliance documentation and reporting
Strong problem-solving and project management skills, with the ability to manage multiple priorities simultaneously
Adaptable with the ability to switch priorities
Fluent in French and English
