The posting
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.
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.
Accountabilities
- 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.
- 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.
- Competitive compensation of $40–$44 CAD per hour.
- 12-month contract with potential for extension.
- Remote working opportunity in Canada.
- Client-facing experience within a global regulatory and clinical development environment.
- Direct exposure to EU MDR and other international medical device regulatory requirements.
- Opportunity to work on technical documentation, regulatory submissions, quality control, and cross-functional regulatory projects.
- Professional development and continued exposure to regulatory best practices, standards, and global requirements.
- Opportunity to collaborate with experienced Regulatory Affairs professionals and diverse international project teams.
- Inclusive and supportive environment that values professional growth, collaboration, and continuous learning.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
#LI-CL1
