Senior RA Associate Consultant – EU MDR

ClinChoice

. Collaborate with the regulatory project team to review, update, and create Technical Documents in accordance with EU MDR and applicable regulatory requirements .

Posted 11/4/2026full-timeRemote • CanadaSenior💰 CA$40 - CA$44 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in EU MDR and global medical device regulatory requirements, with a strong focus on drafting and reviewing Technical Documents. Proficient in collaborating with cross-functional teams and managing regulatory inquiries while ensuring compliance with ISO13485 and FDA regulations.

Highest-signal resume keywords

EU MDR ExpertiseRegulatory Affairs ExperienceTechnical Document CreationISO13485 KnowledgeMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Technical Document CreationRegulatory Requirements IdentificationQuality Control ChecksDocument ManagementRegulatory Submission Preparation

Soft Skills

Strong Organizational SkillsAttention to DetailEffective CommunicationTeam CollaborationProject Management

Tools & Technologies

PLM SystemsAdobe PDFMicrosoft WordMicrosoft ExcelMicrosoft PowerPoint

Industry Keywords

EU MDRFDA Medical Device RegulationsISO13485Regulatory AffairsMedical Device Compliance

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

12 months contract with possibility of extension
Professional development and continuous training
Supportive culture
Inclusive, barrier-free recruitment and selection processes
Equal opportunity employer