Senior Medical Device TPM — Regulatory & Industrialization

Hemerion; France; Hybrid; EUR 65,000 - 75,000; Full time

Benefits offered by this job

Meal vouchers

Company health insurance

Job summary

Hemerion Therapeutics is seeking a skilled Technical Product Manager to own the full lifecycle of our medical devices, from design through production and post‑market surveillance, including hands‑on lab work.

The role requires a minimum of 10 years in medical device development, deep regulatory expertise (CE/FDA), and fluency in English. Collaboration with R&D, QA, and Regulatory Affairs is essential in a fast‑paced, ISO13485 environment.

Qualifications

• Minimum 10 years in medical device development and industrialization.
• Strong command of MDR/CE regulatory frameworks and ISO13485.
• Fluent English, written and spoken, with cross‑functional collaboration.

Responsibilities

• Own full product lifecycle from design to production and post‑market support.
• Coordinate internal teams and external subcontractors across R&D and manufacturing.
• Prepare regulatory documentation for CE marking and FDA submissions.

Skills

Regulatory knowledge

Medical device development

V&V testing

Subcontractor management

Technical writing

Education

Engineering degree or masters

Job description

Between 65,000€ and 75,000€ gross annual (bonus included)

Company

Hemerion Therapeutics is a clinical-stage health tech company pioneering an interventional oncology platform . Built on over a decade of leading academic and clinical research, Hemerion has advanced well beyond its research origins: our technology has already been evaluated in frontline patients harboring brain cancer through a first-in-human clinical trial, and we are now entering a pivotal study phase, a critical milestone that reflects the maturity and clinical validation of our platform. With an expanding footprint in the United States alongside our European base, Hemerion is scaling its operations to match the ambition of its science. To support our product development and strengthen our technical team, we are recruiting an experienced Technical Product Manager with deep expertise in the full medical device development and industrialization cycle.

DESCRIPTION

We are looking for an experienced Technical Product Manager with a minimum of 10 years of experience to own the full product lifecycle of our innovative medical devices – from initial design through design transfer, subcontractor management, production oversight, and post-market surveillance.

The role covers two distinct and complementary product families: active electro-medical devices and single-use sterile ClassIII medical devices. You will act as the end-to-end owner of the R&D and Industrialization processes, coordinating internal teams and external manufacturing subcontractors, while building the regulatory technical files for both CE marking and FDA submissions. The role also includes hands-on activities in a lab and production environment (bench testing, batch management).

LOCATION

On-site — Hemerion Therapeutics, 37 rue Denis Papin, 59650 Villeneuve d’Ascq, France (no remote work). Occasional travel to subcontractors and clinical sites is expected.

RESPONSIBILITIES

Under the supervision of the Chief Technical Officer (CTO), you are responsible for the full product lifecycle of our medical device portfolio, from design through to production and technical file submission.

Design & Development

• Design, document, and continuously improve products by integrating clinical needs and regulatory constraints (MDR2017/745, ISO13485, ISO14971, 21CFR820); manage design changes and maintain design history files (DHF) across the full product portfolio;
• Lead and plan all verification and validation (V&V) activities: define and maintain the V&V matrix, write test protocols and reports, conduct in-house optical and mechanical testing, and manage outsourced tests with full analysis and interpretation of results;
• Manage the metrological monitoring of the experimental equipment fleet: calibration scheduling, in-house and outsourced verification, maintenance, equipment labelling, and purchasing of new instruments;
• Conduct technological and scientific monitoring; protect innovation through patent filings and declaration of inventions.
• Manage design transfer to production: maintain and complete Device Master Records (DMR), manufacturing process documents, and process risk analyses (pFMEA) in coordination with manufacturing subcontractors;
• Oversee equipment and process qualification protocols (IQ/OQ/PQ); plan and manage milestones, budgets, and resources for the prototype / pre-series / full-scale production transition;
• Participate in selecting, qualifying, auditing, and managing subcontractors; maintain proactive communication to ensure quality, timelines, and compliance; handle purchasing and monitoring of supplier orders;

Production

• Oversee sterile device production batches: issue manufacturing orders, manage production follow-up, complete and maintain Device History Records (DHR), and perform lot release;
• Manage stock control activities: periodic inventory, goods receipt inspections, stock entries/exits, and shipment preparation;

Quality

• Act as R&D and Industrialization process owner: uphold QMS procedures, contribute to management reviews, ensure audit readiness, and maintain associated process risk analyses;
• Take an active role in quality processes: contribution to the QMS, software validation, document management, participation in internal and external audits, and follow-up of product-related CAPAs;

Technical file

• Actively contribute to building and maintaining the technical documentation for regulatory submissions, including the CE marking technical file (MDR2017/745) and the FDA submission dossier; act as the operational link with the Regulatory Affairs team to complete all required deliverables (design inputs/outputs, risk management plan and report, usability engineering, substantial equivalence, surveillance plan, etc.).

Technical supervisor

Qualifications

Engineering degree (biomedical, mechanical, materials, or equivalent) or scientific Master’s degree;

• Strong command of medical device regulatory frameworks (MDR2017/745, ISO13485, ISO14971, 21CFR820); familiarity with FDA technical file submission requirements is a strong plus;
• Fluent English (written and oral) which is essential for partner management and international technical documentation.

EXPERIENCE/PROFILE

You have a minimum of 10 years of experience in medical device development, ideally in a startup or deep-tech SME. You independently master the full lifecycle of a medical device: design and development (DHF, design inputs/outputs, risk management, design reviews), V&V testing (bench tests, outsourced biological and sterilization testing, test protocol and report writing), design transfer and DMR management, sterile batch production oversight (DHR, lot release), metrological equipment management, subcontractor qualification and auditing, and stock control. You are hands-on, quickly operational, and comfortable acting as R&D and Industrialization process owner in an ISO13485-certified environment. Experience covering both active electro-medical devices and sterile single-use ClassIII devices is a strong plus. Exposure to dual CE/FDA regulatory pathways and FDA technical file submissions is highly valued. You thrive in a demanding, cross-functional environment with a high level of responsibility.

SKILLS

Required technical and interpersonal skills:

• In-depth knowledge of the medical device development cycle: DHF, design inputs/outputs, risk management (ISO14971), design reviews, usability engineering, V&V matrix;
• Hands-on experience with design transfer: DMR, pFMEA, manufacturing process documentation, IQ/OQ/PQ, sterile batch production management (DHR, lot release);
• Experience in building and maintaining regulatory technical files for CE marking (MDR2017/745) and FDA submissions, in close collaboration with Regulatory Affairs;
• Proficiency in IQ/OQ/PQ methodologies and metrological equipment management (calibration, verification, maintenance);
• Strong quality culture: QMS ownership (ISO13485), CAPA management, software validation, audit readiness, supplier qualification and auditing;
• Experience in managing industrial subcontractors, supplier auditing, and cross-functional coordination across R&D, Quality, and Regulatory;
• Rigor, autonomy, hands-on attitude, and excellent writing skills in both French and English.

PERFORMANCE GOALS

Be fully operational within the first 3 months, with progressive take-over of the product pipeline management.

• Drive key milestones of the industrialization plan within defined timelines and budgets.
• Maintain and improve the regulatory compliance of product technical documentation.
• Ensure effective and proactive management of subcontractors, guaranteeing production quality and timelines.

JOB BENEFITS

Dynamic work environment within an innovative biotech company with strong medical impact. Experienced position with real responsibilities and growth opportunities. Meal vouchers. Company health insurance covered at 100%.

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