QARA Manager (Quality Assurance & Regulatory Affairs)

Apsida Life Science; Paris; Sur place; EUR 100 000 - 125 000; Plein temps

Résumé du poste

A leading life science recruitment firm in Paris seeks a professional to lead the Quality Assurance & Regulatory Affairs function for a medical device start-up. The ideal candidate has at least 4 years of experience in QARA within the medical devices industry. Responsibilities include managing regulatory strategies, maintaining filings, and liaising with health authorities. The position is on-site, offering the chance to impact early skin cancer detection technology.

Qualifications

• Minimum 4 years of experience in Quality Assurance & Regulatory Affairs.
• Experience with electromedical devices is essential.
• Experience with standalone SaMD is a plus.

Responsabilités

• Lead regulatory strategies and manage registrations of the product portfolio.
• Prepare and maintain regulatory filings, improving QMS in line with ISO 13485.
• Act as the key contact with regulatory bodies and health authorities.

Connaissances

Experience in QARA within medical devices

Knowledge of IEC 62304

Knowledge of IEC 60601-1 / 2 standards

Description du poste

Apsida Life Science is currently partnered with a highly innovative medical device start-up in France that has designed a cutting-edge robotic (hardware-software) device focused on transforming dermatological care, with a particular emphasis on early skin cancer detection.

With CE Mark and FDA approval, the organization is preparing to commercialize the product and is seeking a professional to lead the Quality Assurance & Regulatory Affairs function. The successful candidate will work closely with the CEO and CTO. This position is on-site in the heart of Paris.

Responsibilities:

• Lead regulatory strategies and manage registrations of the product portfolio in target markets (EU, US, Australia, Brazil, etc.).
• Prepare and maintain regulatory filings, and improve and update the QMS in accordance with ISO 13485.
• Act as the key contact with regulatory bodies and health authorities.

Requirements:

• Minimum 4 years of experience in QARA within the medical devices industry.
• Experience with electromedical devices is essential. Experience with standalone SaMD is a plus.
• Knowledge of IEC 62304 and IEC 60601-1 / 2 standards.

If you are interested in learning more, please contact Geneva Jones at Apsida Life Science:

Email: [e-mail]

Website: www.apsida.co.uk

Phone: [phone]

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), and Boston (USA). We are dedicated to delivering top talent to the Life Science industry. We aim to provide a cost-effective, high-quality, and trusted recruitment service that prioritizes the candidate experience.