Regulatory Affairs & Quality Assurance Specialist The Ark ·

Chipiron; Paris; Hybride; EUR 60 000 - 85 000; Plein temps

Résumé du poste

Chipiron is a French startup developing ultra-low magnetic field MRI technology. We are looking for a Regulatory Affairs & Quality Assurance Specialist to guide development to global commercialization and ensure patient safety.

You will join the Compliance department, report to the Head of Compliance, and work at the intersection of innovation, product development, and regulatory strategy in a fast-paced startup environment.

Qualifications

• Medical background or equivalent (Pharmacist/Engineer/Master’s in Quality/Regulatory Affairs)
• At least 3 years in QA and RA within medical devices
• Experience with electromedical devices (hardware+software) is a plus
• Strong knowledge of medical device regs and standards incl. ISO 13485, FDA, IEC 62304, ISO 14971, IEC 60601
• Proven experience leading market approvals in the US
• Able to translate regulatory complexity into actionable guidance
• Excellent interpersonal and communication skills
• Detail-oriented with strong problem-solving skills
• Ability to manage multiple priorities in a fast-paced env.
• Fluent English and French (spoken and written)

Responsabilités

• Define regulatory strategy aligned with market access to introduce products in US, EU, and others
• Oversee regulatory submissions and documentation for products and changes
• Collaborate with R&D, Clinical, and Product teams to ensure compliance
• Build and improve a lean, scalable QMS aligned with regulatory requirements
• Lead risk management activities per ISO 14971
• Review and approve labeling and IFU
• Coordinate with R&D and suppliers to ensure product quality from development to production
• Monitor evolving regulations and provide timely regulatory advice
• Manage relationships with Regulatory Authorities and Notified Bodies
• Contribute to cross-functional initiatives including Clinical Affairs support

Connaissances

Regulatory affairs

Quality Assurance

Medical devices regulations

ISO 13485

FDA regulations

Regulatory strategy

QMS implementation

Risk management

US market approvals

Cross-functional collaboration

Formation

Pharmacist / Engineer or Master’s in Quality/Regulatory Affairs

Description du poste

We are looking for a hands-on and strategic Regulatory Affairs & Quality Assurance Specialist to help bring our technology from development to global commercialization. You will join our Compliance department (Quality Assurance, Regulatory Affairs & Clinical Affairs) and report to the Head of Compliance. You will work at the intersection of innovation, product development, clinical validation, and regulatory strategy, helping the company move fast while maintaining the highest standards of quality and patient safety.

Skills & Experience

• Medical or scientific background (Pharmacist, Engineer, Master’s degree in Quality/Regulatory Affairs for medical devices, or equivalent).

• At least 3 years of experience in Quality Assurance and Regulatory Affairs within the medical device industry.

• Experience with electromedical devices combining hardware and software is a strong plus.

• Strong knowledge of medical device regulations and standards, particularly ISO 13485, FDA regulations, IEC 62304, ISO 14971, and the IEC 60601 series.

• Proven experience participating in or leading market approval processes in the US.

• Ability to translate regulatory complexity into clear, actionable guidance for diverse audiences.

• Excellent interpersonal and communication skills.

• Strong problem-solving and critical-thinking abilities, with a detail-oriented mindset.

• Ability to manage multiple priorities effectively in a fast-paced environment.

• Fluent spoken and written English and French.

What Would Make You Successful in This Role

• Strong sense of ownership: You are comfortable working autonomously, taking full ownership of your missions with an entrepreneurial mindset.

• Collaborative mindset: You proactively build strong relationships across teams and know how to create alignment in cross-functional environments.

• Pragmatism: You know how to turn regulatory requirements into practical guidance adapted to fast-moving teams and evolving product development timelines.

• Startup mindset: You enjoy working in an early-stage startup environment, where versatility is key and where you may contribute to initiatives beyond your core area of expertise (for example, supporting Clinical Affairs activities when needed).

Key Responsibilities

• Define the regulatory strategy in alignment with the market access strategy to introduce our products into targeted markets (US, EU, and others).

• Oversee the planning, coordination, and execution of regulatory submission and documentation activities for products and product changes, ensuring timely commercialization in compliance with applicable regulations and standards.

• Partner closely with R&D, Clinical, and Product teams to ensure design and development activities comply with the defined regulatory strategy and applicable regulatory requirements.

• Build, implement, and continuously improve a lean and scalable Quality Management System (QMS) aligned with regulatory requirements and company objectives.

• Lead Risk Management activities in accordance with ISO 14971.

• Review and approve labeling (labels and Instructions for Use).

• Collaborate with R&D teams and suppliers to ensure product quality from development through production and industrialization.

• Monitor and interpret evolving regulations, standards, and industry expectations to provide accurate and timely regulatory advice across the company.

• Manage relationships with Regulatory Authorities and Notified Bodies.

• Contribute to cross-functional initiatives beyond your direct scope when needed, including support to Clinical Affairs activities.

Who We Are

Chipiron is a French startup that is leveraging the emerging properties of ultra-low magnetic fields (<30mT) to build the first light, inexpensive MRI machine without compromising on image quality. We're a team of engineers based in the heart of Paris, and our mission is to revolutionize the medical imaging industry by developing the first plug-and-play, patient-friendly breast MRI that works everywhere.

Our Culture

We are an international, English-speaking team that values technical excellence, interpersonal intelligence, and engagement. At Chipiron, this means we look for people with exceptional analytical ability, who enjoy mastering complex problems and executing with rigor and precision; communicate clearly and concisely, are self-aware and willing to ask for help and to help others when needed; people who go the extra mile, and instinctively move where impact is highest, rather than staying confined to a job description.

The process

1. Screening Interview - Video call (45 min)

2. Short online questionnaire (~20 min)

3. Hiring Manager & CEO Interviews (Order may vary) - Onsite (45 min)

4. Technical Test