Regulatory Affairs Officer - 12 Month Fixed-Term Contract

Joining Mines Saint-Étienne means engaging with an institution where science and innovation build a more sustainable future. An institution of excellence where everyone has the opportunity to reach their full potential and contribute to meeting the challenges of tomorrow.

Ranked among the best engineering schools in France and recognized worldwide, our school, a member of the Institut Mines-Télécom, trains the talents of tomorrow while actively contributing to meeting major industrial, digital, and environmental challenges. With us, you will join a community of 500 employees, 2500 students, and participate in an ambitious project: combining academic excellence, cutting-edge research, and positive societal impact.

The Institut Mines-Télécom unites French engineering schools around major industrial, digital, energy, and ecological challenges. With its 8 public Grandes Écoles and 2 subsidiary schools, it is the leading public institute dedicated to engineers and managers. Together, we imagine and build a sustainable future by training the actors who will shape the transitions of tomorrow.

At Mines Saint-Étienne, our research centers are the beating heart of our School.

Designed as true innovation hubs, our five Training and Research Centers align their expertise around major industrial, environmental, societal, and technological issues.

Their mission? To imagine the world of tomorrow by combining academic excellence and concrete impact.

When technology meets medicine, it creates… the Health Engineering Center (CIS)!

From innovative medical devices (biomechanics, biomaterials, nanoparticles) to digital twins of patients and hospitals, the CIS develops tailor-made solutions to address current health challenges.

🧠 Modeling, simulation, collective intelligence: our teacher-researchers work hand in hand with doctors, industrialists, and institutions.

💙 A single ambition: to improve care and people's lives through science.

🎯 What we expect from you

Within the Health Engineering Center and the MedTechLab, you will contribute to the deployment of a technico-regulatory strategy to secure the development, experimentation, evaluation, and, where applicable, the market launch of innovative health products and services, particularly medical devices and digital health solutions.

The MedTechLab®, co-founded by Mines Saint-Étienne, AÉSIO Santé, and AÉSIO Mutuelle, is an open innovation space dedicated to the co-creation, modeling, testing, and experimentation of health and autonomy innovations. As a laureate of the France 2030 Experimentation Third Places call for projects, it supports industrialists, start-ups, and healthcare and social welfare stakeholders in usage studies, clinical trials, medico-economic analyses, market studies, and processes leading to the development of minimum viable products.

You will support the teams of the MedTechLab and the CIS, in collaboration with academic, hospital, and industrial partners. You will assist projects at their various stages: R&D, regulatory strategy, clinical research, risk management, compilation and maintenance of technical documentation, CE marking, and post-market surveillance.

Objective of the position: to ensure that applicable regulatory and quality requirements are taken into account for MedTechLab projects and to develop a shared culture of regulatory affairs within the ecosystem.

Your main responsibilities:

• Ensure the conformity of activities and processes with applicable standards and contribute to the creation and evolution of quality system and tool documentation.

• Within the framework of the PREMYOM project, support the consortium's internal ethics committee in conjunction with the DPOs of the various partners.

• Identify applicable standards and regulations for MedTechLab's research and innovation projects, conduct regulatory and normative monitoring, and coordinate this monitoring with partners.

• Support the implementation of ISO 14155, ISO 13485, and ISO 14971 standards, particularly for clinical trials, quality management systems, and risk analysis.

• Support teams in clinical research compliance and provide methodological and technical assistance.

• Contribute to CE marking strategies: supervision and drafting of technical files, declarations of conformity, maintenance of compliance documentation, and post-market surveillance.

• Lead the regulatory evaluation of changes, manage the list of standards applied to projects, and handle regulatory and technical questions from health authorities following dossier submissions.

• Within the framework of the GDPR, ensure, in conjunction with the DPOs of Mines Saint-Étienne and AÉSIO Santé, project compliance and adherence to procedures.

• Prepare and lead quality/regulatory affairs meetings, contribute to steering committees, monitor indicators, develop dashboards, and communicate on the continuous improvement process.

• Participate in professional networks and maintain useful relationships with competent authorities and organizations (ANSM, ANS, CNIL, CPP, CNAM, etc.).

• Define product regulatory strategies (classification, market access pathway, target markets: EU, France, then international)

• Monitor regulatory and normative evolutions (MDR 2017/745, IVDR 2017/746, AI Act, GDPR, cybersecurity, health data) and assess their impact

• Anticipate requirements related to innovations (medical device software, AI, connected objects, etc.)

• Manage exchanges with notified bodies

• Raise awareness and train internal teams on regulatory issues

🔍 What we are looking for

You hold a higher education degree in regulatory affairs, quality, or health law:

• Professional license, Master 1, or Master 2 in regulatory affairs, health law, quality applied to health products, or equivalent qualification are preferred. Also, initial experience in regulatory affairs in the health sector (medical devices, e-health, or pharmaceuticals). Motivated junior profiles will be considered depending on the context.

Knowledge sought:

• Regulation of medical devices and associated standards, particularly Regulation (EU) 2017/745 (MDR), ISO 13485, ISO 14155, and ISO 14971.

• Clinical research regulation, good clinical practice, GDPR, clinical research procedures, innovative health project development cycle, medical and scientific vocabulary.

Skills expected:

• Ability to identify and interpret regulatory and normative requirements applicable to a project, and to translate them into operational actions.

• Proficiency in risk analysis, problem-solving, and document management methods; ability to contribute to technical files and CE marking dossiers.

• Ability to lead cross-functional projects, to argue for quality assurance/regulatory affairs solutions, and to work with academic, clinical, industrial, and institutional stakeholders.

• Proficiency in office automation tools and ability to develop monitoring tools, indicators, and dashboards.

• Written scientific English; ability to communicate in English in a professional context is appreciated.

Personal qualities:

• Autonomy, rigor, organization, sense of priorities, versatility, and adaptability; respect for professional secrecy, ethics, and current regulations.

• Curiosity for innovation and ability to find compliant solutions

• Interpersonal skills, team spirit, and ability to communicate with diverse partners. Occasional travel within France may be required depending on projects.

Professional relationships: investigating physicians, CRAs, clinical research project managers, biostatisticians, data managers, MedTechLab and CIS teams, AÉSIO partners, clinical and technological research structures, start-ups and industrialists, as well as competent administrative and regulatory bodies.

🌍 Why join Mines Saint-Étienne?

We support each of our employees on the path to excellence, with the conviction that together, we can have a lasting and significant impact on our world.

Joining Mines Saint-Étienne offers the opportunity to find:

· A stimulating environment: cutting-edge experimental resources, a strong international network (T.I.M.E., EULIST), and human-sized campuses with an urban environment

· A real impact: contract research projects totaling €11 million per year, mainly with industrial partners, a scientific culture center, La Rotonde, which has been involved in science dissemination for 25 years with over 50,000 visitors annually

· An incomparable quality of life: 49 days of leave and compensatory time off, partial remote work, 75% coverage of public transport costs, financial support for carpooling and cycling, and a social barometer where 83% of employees praise their quality of work life.

Let's build a more sustainable future through science, engineering, and meaningful projects.

📩 Apply now!

Application deadline: 10/15/2026

🔗 Application files (CV, cover letter, letter of recommendation if applicable, ID) should be submitted on the RECRUITEE platform

https://institutminestelecom.recruitee.com/o/chargee-ou-charge-daffaires-reglementaires-cdd-12-mois

As part of its Equality, Diversity, and Inclusion policy, Mines Saint-Étienne is an employer committed to fair treatment of all applications.

 Additional information

·  Desired start date: 11/06/2027

·  Salary will be determined based on the candidate's profile, in accordance with the rules defined by the management framework of the Institut Mines Télécom.

·  The positions offered are open to all, with accommodations available upon request for candidates with disabilities.

·  Contractual employment

·  In the medium term, a permanent position may become available

·  All applications may be subject to an administrative investigation

Candidates selected after reviewing their application will be interviewed on 11/10/2026 in Saint-Étienne.

📞 Contacts

·  Regarding the position content:
Vincent AUGUSTO – Professor, Director of the CIS
Email :
Phone: +33 (0)4 77 42 66 26

·  Regarding administrative/HR aspects:

Milica PETKOVIC– HR Manager

Email :   
Phone: +33 (0)4 77 42 02 08 

Useful links:

School:

https://www.mines-stetienne.fr/

IMT:

Protection of your

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