Regulatory Affairs Specialist

Surgitec Robotics develops Surge One, a new generation of AI-assisted surgical robotics designed for hard-tissue procedures such as neurosurgery, spine, orthopedics and ENT

Role

The Regulatory Affairs Specialist is the regulatory architect of our robotic surgery assistance platform: they translate every requirement from certification bodies (EU and US) into practical, actionable steps.

A true co-pilot of innovation, they proactively identify the most favorable regulatory pathways and turn compliance into a competitive advantage rather than a barrier to development.

In a startup environment, they contribute to building the regulatory strategy, anticipate the expectations of notified bodies, and prepare the company for its first CE and FDA submissions.

With a facilitative approach, they act as a trusted partner for R&D, Quality, and Leadership teams, always proposing pragmatic solutions.

Attributions

1. Regulatory Strategy & Planning

• Drive the overall regulatory strategy for our robotic surgery assistance platform as defined by management for the European (MDR 2017/745) and U.S. (FDA 510(k)) markets
• Select and manage relationships with the Notified Body (NB): audit preparation, document reviews, and responses to questions
• Conduct international regulatory intelligence (MDR, FDA, IEC 62304, IEC 60601, etc.) and assess impacts on the development program
• Advise Management and R&D on regulatory milestones, non-compliance risks, and opportunities for accelerated pathways
• Define the device classification and optimal regulatory pathway in collaboration with technical teams

2. Technical Documentation & Regulatory Submissions

• Prepare, maintain, and submit the Technical File / Design Dossier with support from R&D and in collaboration with the QA Specialist
• Write and coordinate dossier sections: device description, clinical data, performance evaluation, risk management (ISO 14971)
• Prepare FDA submissions: 510(k) pre-submissions, Q-submissions, and responses to Additional Information Requests (AIR)
• Manage product registrations (EUDAMED, FDA GUDID) and CE certificate renewals

3. Regulatory Integration into Product Development

• Participate in Design Reviews from the conceptual phase to anticipate applicable regulatory requirements
• Define and maintain the list of applicable standards (IEC 62304, IEC 60601-1, etc.) and ensure their integration into V&V plans
• Contribute to writing specifications and regulatory requirements within the Design History File (DHF)
• Assess the regulatory impact of each product modification (change control) and determine whether a new submission is required

4. Clinical Evaluation & Post-Market Data

• Contribute to drafting and updates of the Summary of Safety and Clinical Performance (SSCP), Clinical Evaluation Report (CER), and Periodic Safety Update Report (PSUR)
• Lead the Post-Market Clinical Follow-up (PMCF) plan and Post-Market Surveillance (PMS) plan in compliance with MDR
• Manage vigilance obligations: reporting serious incidents, Field Safety Corrective Actions (FSCA), and FSCA communications to users

5. Labelling, IFU & Product Documentation

• Review Instructions for Use (IFU), labels, and product documentation in accordance with MDR Annex I and applicable standards
• Ensure labelling compliance with the specific requirements of each target market (UDI, symbols, translations)
• Manage the Unique Device Identification (UDI) system: code assignment, EUDAMED / GUDID registration, and maintenance

6. Training & Internal Regulatory Culture

• Train and raise awareness among teams—particularly R&D, Quality, and Production—on applicable regulatory requirements
• Produce clear and accessible regulatory summaries for non-specialist audiences (management, investors)
• Contribute to drafting internal SOPs related to regulatory affairs
• Represent the company during interactions with competent authorities (ANSM, FDA) and notified bodies

Expected Profile

Education

• Master’s degree (MSc or Engineering degree) in Quality, Biomedical Engineering, Life Sciences, Mechatronics, Pharmacology, or equivalent
• A specialization or certification in Regulatory Affairs (RAC (RAPS), EU QP, ISO 13485 Lead Auditor) is an asset
• Knowledge of AI regulations in Europe and the United States
• Knowledge of regulations related to medical device cybersecurity in Europe and the United States
• Additional training in clinical evaluation (MEDDEV, MDR) or medical device law is a plus

Experience

• 5 to 7 years of experience in a Regulatory Affairs role within the complex medical device sector (hardware, software, and artificial intelligence)
• Proven experience with Class IIb or III active medical devices, ideally with a software component
• Experience with active medical devices, implantables, and robotic surgery is highly valued
• Participation in at least one CE submission (MDR or MDD) and/or FDA 510(k) / PMA submission is mandatory
• Experience managing relationships with a Notified Body is valuedExperience in a startup or innovative SME environment: ability to build a regulatory function “from scratch”

Knowledge

• Strong proficiency of EU Regulation 2017/745 (MDR): General Safety and Performance Requirements (GSPR), Annexes I to XVII
• Knowledge of key harmonized standards: IEC 62304, IEC 60601, ISO 14971, ISO 13485, ISO 15223, ISO 10993
• Mastery of FDA requirements: 21 CFR Part 820, CDRH guidance documents, and 510(k) / De Novo / PMA pathways
• Knowledge of the clinical evaluation framework (MEDDEV 2.7/1 rev.4, MDCG 2020-5/6/13) and clinical investigations (ISO 14155)
• Proficiency in UDI requirements (MDR Annex VI) and the EUDAMED system
• Knowledge of cybersecurity requirements applicable to medical devices (FDA guidance, MDCG )

Know-how

• Drafting Technical Files and Design Dossiers compliant with MDR Annex II
• Structuring and writing 510(k) submissions, Pre-Submissions (Q-Sub), and responses to FDA questions
• Leading and contributing to Clinical Evaluation Reports (CER) and systematic literature reviews
• Ability to produce clear regulatory summaries for non-technical audiences
• Conducting or coordinating MDR gap analyses and associated remediation plans
• Managing regulatory registrations: EUDAMED, FDA 510(k) databases, PMA modules
• Assessing the regulatory impact of product modifications (change control analysis)

Interpersonal skills

• Development facilitator: turning regulatory requirements into opportunities for product robustness and accelerated time-to-market
• Strong communication and teaching skills: making complex requirements understandable for engineers, surgeons, and investors
• Startup mindset and pragmatism: prioritizing, simplifying, and building risk-proportionate processes (right-sized compliance)
• Curiosity: actively monitoring regulatory developments
• Resilience and adaptability: navigating regulatory uncertainty typical of innovative devices and startup environments

Language

• Make a real impact : Contribute to technologies that improve surgical precision and patient outcomes, transforming lives every day.
• Work at the forefront of innovation : Be part of a pioneering team developing next-generation surgical robotics, combining engineering, AI, and healthcare expertise.
• Collaborate with passionate experts : Work alongside talented professionals from diverse backgrounds, all driven by a shared mission to advance healthcare.