Regulatory Affairs Consultant – Medical Devices

Ividata Life Sciences

. Draft and review regulatory documents for clinical investigations involving medical devices, including protocols, Investigator’s Brochures (IBs), and regulatory dossiers .

Posted 10/1/2026full-timeParis • FranceJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory writing and compliance with Medical Device Regulation (MDR) 2017/745, with a strong focus on drafting clinical investigation documents and managing submissions to regulatory authorities. Proven ability to collaborate effectively with cross-functional teams in a multi-project environment.

Highest-signal resume keywords

Regulatory WritingMedical Device Regulation (MDR) 2017/745Clinical SubmissionsDocument ManagementInterpersonal Skills

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document DraftingClinical Evaluation Plans/Reports (CEP/CER)Investigator’s Brochures (IBs)Clinical Investigation DossiersRegulatory DossiersQuality AssuranceData TraceabilityRegulatory StrategyMulti-Project ManagementAnalytical Skills

Soft Skills

Detail-OrientedIndependentProactiveStrong CommunicationCross-Functional Collaboration

Industry Keywords

Medical Device SectorPharmaceutical IndustryEuropean AuthoritiesANSMEMAClinical InvestigationsEthics CommitteesInternational ContextClass II/III DevicesBiomedical Engineering

About the role

Key responsibilities & impact

Draft and review regulatory documents for clinical investigations involving medical devices, including protocols, Investigator’s Brochures (IBs), and regulatory dossiers
Contribute to the preparation of submissions to competent authorities and ethics committees in a European and/or international context
Ensure documents comply with the Medical Device Regulation (MDR) 2017/745 and applicable guidelines
Collaborate with clinical, quality, biometrics, and regulatory affairs teams
Contribute to regulatory strategy for medical device clinical investigations
Ensure the quality, consistency, and traceability of data in produced documents
Contribute to document management and the updating of regulatory templates
Provide consulting services to pharmaceutical and biotechnology clients on high-value projects

Requirements

What you’ll need

Education: Pharmacist, biomedical engineer, or equivalent scientific qualification
Minimum of 2 years’ experience in regulatory affairs and/or medical writing within the medical device or pharmaceutical industry, including projects involving medical devices
Excellent command of regulatory writing for clinical investigations
Good knowledge of the medical device regulatory framework (MDR 2017/745)
Experience with clinical submissions to competent authorities and ethics committees
Proficiency in clinical documents, including protocols, Investigator’s Brochures (IBs), Clinical Evaluation Plans/Reports (CEP/CER), and clinical investigation dossiers
Ability to work in multi-project environments
Experience in the medical device sector, ideally with Class II/III devices
Experience in an international, multicentre environment
Knowledge of interactions with European authorities, particularly ANSM and EMA, is a plus
Rigorous and detail-oriented approach
Analytical mindset and strong ability to synthesize information
Independent and proactive
Strong interpersonal skills and ability to interact with cross-functional teams
Ability to manage multiple projects simultaneously in demanding environments
Fluent professional English

Benefits

Comp & perks

Stimulating, collaborative, and continuously evolving environment
High-impact assignments
Hybrid working with the possibility of remote work
Collaboration with experts and leading organizations across the pharmaceutical, biotechnology, medical device, animal health, cosmetics, and nutrition sectors
Involvement across the full product lifecycle
Opportunities to apply your expertise across five key areas: biometrics, clinical operations, regulatory affairs, pharmacovigilance, and quality assurance