Regulatory Affairs Manager — Medical Devices (Remote)

Women First; Lyon; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Remote work 2 days/week

Job summary

Nemera, a leading global medical device manufacturer, is seeking a Regulatory Affairs Manager based in Lyon (7e). You will lead Regulatory & Compliance activities for ENTD, Ophthalmic and Inhalation products, shaping regulatory strategies across EU, US and Canada.

You will collaborate with development, quality, logistics and commercial teams, supervise a Regulatory & Compliance team, and ensure oversight through ISO13485, MDR 2017/745, and post‑market activities.

Qualifications

• Master’s degree in life sciences or related field with regulatory emphasis.
• 8+ years in medical devices, preferably with combination products.
• Experience leading regulatory projects and teams.

Responsibilities

• Lead Regulatory & Compliance for ENTD, Ophthalmic and Inhalation products.
• Oversee regulatory strategies, submissions and lifecycle activities.
• Coordinate with development, quality, and operations teams.
• Support audits and regulatory interactions with authorities and customers.
• Guide notifications in EU/US/Canada and maintain QMS alignment.

Skills

Regulatory leadership

Team management

MDR 2017/745

ISO 13485

IEC 62304

ISO 10993

English proficiency

Cross-functional collaboration

Education

Master's degree or higher

Job description

Nemera, a leading global medical device manufacturer, is seeking a Regulatory Affairs Manager based in Lyon (7e). You will lead Regulatory & Compliance activities for ENTD, Ophthalmic and Inhalation products, shaping regulatory strategies across EU, US and Canada.

You will collaborate with development, quality, logistics and commercial teams, supervise a Regulatory & Compliance team, and ensure oversight through ISO13485, MDR 2017/745, and post‑market activities.