Senior RA Associate Consultant – EU MDR

This is a fully remote position, open to applicants in Canada.

📋 Description

• Collaborate with the regulatory project team to review, revise, and create Technical Documents in compliance with EU MDR and relevant regulatory standards.

• Develop and sustain a comprehensive understanding of EU MDR and global medical device regulatory frameworks.

• Identify relevant regulatory standards, harmonized guidelines, guidance documents, and submission prerequisites.

• Draft, create, and revise Technical Documents in conjunction with the Platform RA Subject Matter Expert (SME).

• Review, gather, and integrate TF/DD documents from PLM or similar regulatory sources into Adobe PDF formats.

• Create and upload bookmarks and indexes of Adobe PDF files into PLM through Change Orders.

• Conduct quality control assessments to ensure completeness, proper pagination, absence of blank or missing pages, necessary approvals, and current revisions.

• Collaborate with cross-functional teams and local affiliates to secure supporting documents.

• Address inquiries from local affiliates and manage health authority-related questions or requests.

• Represent Regulatory Affairs on project teams and communicate regulatory requirements.

• Participate in meetings and maintain communication with the project team.

• Update regulatory management on project status and deliverables.

• Assist with additional regulatory tasks as assigned.

⛳️ Requirements

• Bachelor's degree (preferably in life sciences).

• At least 2 years of experience in Regulatory Affairs with a focus on EU MDR.

• Expertise in EU MDR, ISO13485, and FDA Medical Device regulations is essential.

• Proficiency in Microsoft Office applications (e.g., Word, Excel, PowerPoint).

• Capability to work in team settings and on projects of varying scope with minimal oversight.

• Excellent organizational skills and meticulous attention to detail.

• Strong planning and communication abilities.

• Proficient written and verbal communication skills in English.

• Must reside in Canada.

🏝️ Benefits

• 12-month contract with the potential for extension.

• Opportunities for professional development and ongoing training.

• Supportive work culture.

• Inclusive and barrier-free recruitment and selection procedures.

• Equal opportunity employer.