About the role

Senior Regulatory Affairs Consultant supporting EU MDR technical documentation and quality control. Joining ClinChoice, a global CRO serving pharmaceutical, biotechnology, medical device, and consumer health companies.

Responsibilities

Collaborate with the regulatory project team to review, update, and create Technical Documents in accordance with EU MDR and applicable regulatory requirements
Establish and maintain understanding of EU MDR and global medical device regulatory requirements
Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations
Draft, create, and update Technical Documents with the Platform RA SME
Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into Adobe PDF files
Create and upload bookmarks/indexes of Adobe PDF files into PLM via Change Orders
Perform quality control checks for completeness, pagination, blank or missing pages, approvals, and current revisions
Work with cross-functional teams and local affiliates to obtain supporting documents
Respond to local affiliate inquiries and coordinate health-authority-related questions or requests
Represent Regulatory Affairs on project teams and report regulatory requirements
Attend meetings and communicate with the project team
Communicate project status and deliverables to regulatory management
Support other regulatory activities as assigned

Bachelor’s degree (life sciences preferred)
Minimum of 2 years of working experience in Regulatory Affairs focused on EU MDR
Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations is mandatory
Working proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint)
Ability to work in team environments and on projects of diverse scope with minimal supervision
Strong organizational skills and attention to detail
Good planning and communication skills
Strong written and verbal English communication skills
Must be based in Canada