Regulatory Affairs Manager

Barrington James; Paris; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A startup medical device company in Paris is seeking a Regulatory & Quality Affairs Manager to oversee regulatory and quality functions. You will work closely with the CEO and cross-functional teams ensuring compliance and guiding products to market. We are looking for candidates with 5+ years of QARA experience in the medical device industry and strong knowledge of relevant standards. Competitive compensation and a collaborative work culture are offered.

Prestations

Competitive compensation package

Collaborative work culture

Centrally located office in Paris

Qualifications

• 5+ years of QARA experience in the medical device industry, preferably with electromedical devices.
• Strong knowledge of standards such as IEC 62304 and IEC 60601-1/2.
• Experience in applying regulatory requirements in agile, startup settings.

Responsabilités

• Maintain and improve QMS in accordance with ISO 13485 and 21 CFR requirements.
• Develop and execute regulatory strategies throughout the product lifecycle.
• Prepare and update technical documentation for CE and FDA submissions.

Connaissances

QARA experience

Knowledge of IEC standards

Fluent English communication

Proactive and meticulous

Experience in startup settings

Description du poste

The Company

We have partnered with a startup medical device company in Paris that is transforming how skin screenings are performed by combining robotics and advanced medical imaging. Based in the heart of Paris, this startup has gained recognition through features on CNBC, M6, and BFM for their innovative solutions.

Their flagship device is the world’s first high-resolution, full-body skin scanner, fully automated and capable of completing a scan in minutes. This device aims to enhance patient care and improve diagnostic workflows.

The Role

We’re seeking an experienced and proactive Regulatory & Quality Affairs (QARA) Manager to oversee our regulatory and quality functions. You will collaborate closely with our CEO/CTO and cross-functional teams to ensure compliance as we expand globally.

You will serve as the main contact for regulatory bodies, ensuring adherence to standards and guiding the product to market efficiently and effectively.

Key Responsibilities

1. Maintain and improve our QMS in accordance with ISO 13485 and 21 CFR requirements.
2. Develop and execute regulatory strategies throughout the product development lifecycle.
3. Prepare and update technical documentation for CE and FDA submissions.
4. Coordinate with Marketing/Communications to ensure promotional compliance.
5. Act as the regulatory liaison with health authorities and notified bodies.
6. Monitor regulatory changes and advise on their implications.
7. Lead or support registration and certification processes for global markets including the EU, US, and Australia.

About You

You will excel in this role if you are proactive, meticulous, and capable of working across teams in a fast-paced environment. We are looking for someone who:

• Has 5+ years of QARA experience in the medical device industry, preferably with electromedical devices.
• Possesses strong knowledge of standards such as IEC 62304 and IEC 60601-1/2.
• Knows how to apply regulatory requirements in agile, startup settings.
• Communicates fluently in English, both written and spoken (all documentation is in English).
• Is hands-on, autonomous, and willing to go the extra mile.
• Has experience with standalone SaMD and/or within startup or fast-growth medical companies.

What They Offer

• Competitive compensation package.
• A collaborative and friendly work culture.
• A centrally located office in Paris.
• The opportunity to make a significant impact on global healthcare.

Interested in this position? Apply now!

[e-mail]

44 (0) 1293 776644