Regulatory Affairs Manager - Hybrid, Medical Devices

Nemera; Lyon; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Remote work 2 days/week

Job summary

Nemera, based in Lyon, seeks a Regulatory Affairs Manager to lead regulatory and compliance activities across ENTD, Ophthalmic and Inhalation devices. You will report to the Global Regulatory & Compliance Manager and collaborate with development, quality, and operations teams to ensure regulatory readiness throughout product lifecycles.

You will build regulatory strategies, manage audits and interface with authorities, customers, and external groups, while developing the team and supporting

Qualifications

• 8+ years of professional experience in medical devices / combination products.
• Experience in leading Regulatory & Compliance projects.
• Experience with ISO 13485 and ISO 14971.
• Strong English skills (written and spoken).
• Experience in multicultural and interdisciplinary environments.

Responsibilities

• Lead Regulatory & Compliance team for ENTD, Ophthalmic, and Inhalation products.
• Define regulatory strategy and impact assessments for changes.
• Collaborate with development, quality, and manufacturing teams for regulatory activities.
• Prepare and review regulatory documents and support audits.
• Support customers in notification procedures in EU, US, and Canada.
• Drive continuous improvement of regulatory processes.

Skills

Regulatory affairs

Team leadership

English proficiency

Regulatory strategy

Analytical skills

Education

Master’s degree in life sciences or Regulatory Affairs

Job description

Nemera, based in Lyon, seeks a Regulatory Affairs Manager to lead regulatory and compliance activities across ENTD, Ophthalmic and Inhalation devices. You will report to the Global Regulatory & Compliance Manager and collaborate with development, quality, and operations teams to ensure regulatory readiness throughout product lifecycles.

You will build regulatory strategies, manage audits and interface with authorities, customers, and external groups, while developing the team and supporting