Sr. RA Associate Consultant

CanadaRemoteFull-timesenior

OtherConsultant

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Quick Summary

Overview

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. RA Associate Consultant based in Canada.

Technical Tools

OtherConsultant

This is a client-facing Regulatory Affairs consulting opportunity supporting medical device regulatory activities in a collaborative project environment. You will work closely with regulatory project teams to develop, update, review, and maintain technical documentation in line with EU MDR and other applicable requirements. The role combines regulatory knowledge with detailed document management, quality control, and cross-functional coordination. You will help ensure regulatory submissions and supporting documentation are accurate, complete, current, and compliant. The position requires strong independence, organization, and communication skills, while maintaining close collaboration with regulatory experts, local affiliates, and project stakeholders. This 12-month contract, with potential for extension, offers meaningful exposure to global medical device regulatory work and a trusted client-facing environment.

Collaborate with regulatory project teams to review, create, and update technical documentation in accordance with EU MDR and other applicable medical device regulatory requirements.
Maintain a strong understanding of EU MDR and relevant global medical device regulations, standards, guidance documents, and submission expectations.
Identify applicable regulatory requirements and submission considerations and apply them appropriately to assigned projects.
Draft, create, and update technical documentation in collaboration with Regulatory Affairs subject matter experts.
Retrieve, review, and consolidate technical file and design documentation from PLM or similar regulatory systems into organized Adobe PDF files.
Create and upload bookmarks, indexes, and supporting documentation into PLM systems through appropriate change-control processes.
Perform detailed quality control checks to confirm document completeness, correct pagination, absence of blank or missing pages, current revisions, and required approvals.
Coordinate with cross-functional teams and local affiliates to obtain supporting documentation and resolve regulatory documentation requirements.
Respond to inquiries from local affiliates and proactively coordinate health-authority-related questions or requests with regulatory management and relevant cross-functional stakeholders.
Represent Regulatory Affairs on project teams and communicate regulatory requirements, project updates, and deliverables according to agreed timelines and formats.
Participate in project meetings and maintain clear, timely communication with project stakeholders and regulatory management.
Support additional Regulatory Affairs activities and projects as assigned.

Requirements

~1 min read

Hold a Bachelor’s degree, preferably in life sciences or a related discipline.
Bring at least 2 years of professional Regulatory Affairs experience with a focus on EU MDR.
Possess mandatory knowledge of EU MDR, ISO 13485, and FDA medical device regulations.
Demonstrate strong working proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
Be comfortable working independently on projects of varying scope, evaluating multiple factors and data points while requiring minimal supervision.
Demonstrate strong organizational and planning skills, with exceptional attention to detail and the ability to manage multiple regulatory deliverables effectively.
Possess strong written and verbal English communication skills and the confidence to work directly with clients and cross-functional stakeholders.
Be a proactive self-starter who works effectively in collaborative environments and can establish trusted working relationships with project counterparts.
Demonstrate sound judgment, analytical thinking, and the ability to identify and resolve documentation or regulatory issues proactively.