Regulatory Affairs Project Manager (Medical Devices)

Location: Lyon, France; headquarters-based, full-time

Company

hirify.global manufactures complex drug delivery systems and provides product development, industrialization, manufacturing, and contract manufacturing services for the pharmaceutical industry.

What you will do

• Lead regulatory and compliance design projects for drug delivery devices from requirements through post-marketing activities.
• Define regulatory strategies and support quality management plans, QMS development, and process improvement.
• Prepare, verify, approve, and submit regulatory documents for authorities, notified bodies, and customers.
• Coordinate regulatory and normative activities with development teams and production sites, including resource assessment.
• Support audits, laboratory verification plans and reports, corrective and preventive actions, and interactions with external stakeholders.
• Monitor standards, analyze product-change impacts, assess compliance gaps, and contribute to standardization committees and expert groups.

Requirements

• Engineering degree or equivalent and at least 5 years of professional experience.
• Experience in combination products or the medical devices industry within multicultural and interdisciplinary environments.
• Experience with eCTD Module 3 CMC, CE certification, Notified Body Opinion processes, and leading transversal regulatory and compliance projects.
• Knowledge of quality management systems, GMP, 21 CFR Part 820, ISO 13485, ISO 14971, MDR 2017/745, medical device design, and generic drugs.
• Fluent spoken and written English is required.
• Occasional travel and the ability to work effectively both independently and collaboratively.

Nice to have

• Knowledge of ISO 11608 and ISO 23908.

Culture & Benefits

• Work in an international pharmaceutical-device manufacturing group with teams across multiple countries.
• Patient-first culture focused on products that improve patients’ lives.
• Environment emphasizing collaboration, accountability, flexibility, learning, and problem solving.
• Commitment to diversity, inclusion, equal opportunity, and accessibility.

Hiring process

• CV review followed by an initial screening call with Talent Acquisition.
• Interviews with the Hiring Manager, N+2 management, and the HR Manager.
• Offer after successful completion of the interview process.