Regulatory Affairs Manager M/F/X (CDI)

Location: Lyon, France; hybrid work with the possibility of working from home 2 days per week

Company

hirify.global develops and manufactures drug delivery systems and medical devices, including inhalation, injection, nasal, dermal, and ophthalmic products, for pharmaceutical customers worldwide.

What you will do

• Lead Regulatory & Compliance activities for ENTD, ophthalmic, and inhalation products and combination products.
• Manage and develop the Regulatory & Compliance team for the relevant business units.
• Define regulatory strategies, assess regulatory impacts of product changes, and support product platforms throughout the lifecycle.
• Coordinate with development, quality, industrialisation, operations, commercial teams, production sites, customers, and external stakeholders.
• Support regulatory notifications and submissions, particularly in the EU, US, and Canada, including preparation and approval of regulatory documentation.
• Monitor standards, support audits and corrective actions, contribute to QMS improvement, and participate in standardisation committees or expert groups.

Requirements

• Master’s degree or higher in life sciences or another relevant scientific discipline, such as pharmacy or regulatory affairs.
• At least 8 years of professional experience with combination products in the pharmaceutical, biomedical, or medical-device industry.
• Experience managing and developing teams and leading cross-functional Regulatory & Compliance projects.
• Experience with ISO 13485 quality management systems and ISO 14971 risk management.
• Advanced knowledge of MDR 2017/745 and awareness of IEC 62304 and ISO 10993.
• Good spoken and written English is required; the resume should be submitted in English.

Nice to have

• Experience working in multicultural and interdisciplinary environments.
• International committee experience.

Culture & Benefits

• Work in an international medical-device manufacturing group focused on improving patients’ lives.
• Collaborative environment with cross-functional and customer-facing responsibilities.
• Hybrid work arrangement with up to 2 home-working days per week.
• Some business travel is required.
• Equal-opportunity and inclusive workplace committed to dignity and respect.