Regulatory Affairs Specialist

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Job Details

This role is a maternity coverage from November to end of May 2027

Hybrid role with 3 days on site in Signy

Role Overview

The Regulatory Affairs Coordinator, MedSurg / Apheresis is responsible for coordinating and tracking day-to-day regulatory activities to support timely submissions and ensure compliance with applicable local and international regulatory requirements.

The role supports Regulatory Affairs activities throughout the different phases of the regulatory process, including documentation management, product registrations, technical documentation, certifications and audit preparation. The Regulatory Affairs Coordinator works closely with internal teams, distributors and other external stakeholders to ensure regulatory activities are completed accurately and on time.

The incumbent may also perform other Regulatory Affairs-related activities as reasonably required by business needs.

Key Responsibilities

• Coordinate, obtain, notarize, legalize, compile and distribute documentation required to support international regulatory submissions.
• Organize, maintain and archive regulatory submission files and records within RIMSys.
• Maintain and update product registration metadata in regional and national regulatory databases, including EUDAMED and applicable national databases.
• Communicate and coordinate with internal stakeholders, distributors and other external partners regarding regulatory documentation and registration activities.
• Contribute to the preparation and maintenance of EU Technical Files and ensure appropriate documentation is stored within the Agile document repository.
• Prepare, request and track government certificates and related documentation required to support new product registrations in global markets.
• Support Regulatory Affairs activities related to product registrations and regulatory submissions from initiation through completion.
• Assist with preparation for internal and external audits.
• Prepare regulatory metrics, reports and other information to support Regulatory Affairs activities and business requirements.
• Create and track requisitions and Purchase Orders related to Regulatory Affairs activities.
• Review, maintain and update Standard Operating Procedures (SOPs) and related regulatory documentation.
• Monitor and manage the Regulatory Affairs general email inbox and coordinate follow-up actions as required.
• Provide general administrative and documentation support to Regulatory Affairs team members.

Requirements

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality, Business Administration, or a related field preferred.
• Previous experience in Regulatory Affairs, Quality, Medical Devices, or a regulated environment is preferred.
• Good understanding of regulatory documentation and document control processes.
• Knowledge of EU Medical Device Regulations and regulatory databases such as EUDAMED is an advantage.
• Experience with Regulatory Information Management systems (RIMSys) and document management systems such as Agile is an advantage.
• Strong organizational skills with the ability to manage multiple activities, priorities and deadlines.
• High attention to detail and accuracy when handling regulatory documentation and data.
• Good communication skills and ability to work effectively with internal teams, distributors and external stakeholders.
• Comfortable working with databases, Microsoft Office tools and reporting activities.
• Fluent in English and French
• Proactive, reliable and comfortable working independently as well as within a team.

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