Regulatory Affairs & Quality Consultant

EPM Scientific; Lyon; Sur place; EUR 90 000 - 150 000; Plein temps

Résumé du poste

EPM Scientific is seeking an experienced Regulatory Affairs & Quality Consultant to lead regulatory and quality initiatives for drug delivery and combination products in Lyon, France.

You will drive EU MDR regulatory strategy, manage submissions, support ISO 13485 compliant QMS, prepare technical files, and liaise with Notified Bodies, authorities, and auditors while partnering with Engineering, R&D, and Operations to achieve market access.

Qualifications

• Proven Regulatory Affairs experience within medical devices, combination products, or drug delivery systems.
• Strong knowledge of EU MDR, ISO 13485, and product development lifecycle requirements.
• Experience preparing technical files, regulatory submissions, and supporting product registrations.
• Previous interaction with Notified Bodies, regulatory authorities, and external audit teams.
• Ability to operate independently and drive complex regulatory projects within a fast-paced environment.

Responsabilités

• Lead regulatory strategy and execution for drug delivery and medical device projects across global markets.
• Drive regulatory submissions, registrations, and lifecycle management activities in the EU and other key regions.
• Support the development, enhancement, and ongoing effectiveness of the Quality Management System in line with ISO 13485.
• Prepare and review technical documentation, regulatory dossiers, and design control documentation.
• Act as the primary point of contact for regulatory agencies, Notified Bodies, and external auditors.
• Provide regulatory guidance throughout product development, verification, validation, and design transfer activities.
• Support risk management, change control, and compliance activities across product portfolios.
• Partner with Engineering, R&D, Quality, and Operations teams to deliver key regulatory and business objectives.

Connaissances

Regulatory affairs

Regulatory submissions

Quality management

Description du poste

We're supporting an established medical technology organisation developing innovative drug delivery and combination products. They are seeking an experienced Regulatory Affairs & Quality Consultant to lead key regulatory and quality initiatives, ensuring products meet global regulatory requirements and supporting critical market access objectives. This assignment is ideal for an independent consultant with strong experience across medical devices, combination products, drug delivery systems, and quality management systems.

Key Responsibilities

• Lead regulatory strategy and execution for drug delivery and medical device projects across global markets.
• Drive regulatory submissions, registrations, and lifecycle management activities in the EU and other key regions.
• Support the development, enhancement, and ongoing effectiveness of the Quality Management System in line with ISO 13485.
• Prepare and review technical documentation, regulatory dossiers, and design control documentation.
• Act as the primary point of contact for regulatory agencies, Notified Bodies, and external auditors.
• Provide regulatory guidance throughout product development, verification, validation, and design transfer activities.
• Support risk management, change control, and compliance activities across product portfolios.
• Partner with Engineering, R&D, Quality, and Operations teams to deliver key regulatory and business objectives.

Key Requirements

• Proven Regulatory Affairs experience within medical devices, combination products, or drug delivery systems.
• Strong knowledge of EU MDR, ISO 13485, and product development lifecycle requirements.
• Experience preparing technical files, regulatory submissions, and supporting product registrations.
• Previous interaction with Notified Bodies, regulatory authorities, and external audit teams.
• Ability to operate independently and drive complex regulatory projects within a fast-paced environment.