Senior Regulatory Affairs Consultant – EU MDR Expert

ClinChoice; Canada; On-site; CAD 114,616,000 - 126,078,000; Full time

Job summary

ClinChoice Canada Inc. is seeking a Sr. Regulatory Affairs Associate – CONSULTANT to join its global CRO team on a 12‑month contract.

You will work closely with regulatory project teams to review, draft, and manage Technical Documents for EU MDR and other regulatory needs, ensuring accuracy and timely delivery. The role requires at least 2 years in Regulatory Affairs focused on EU MDR, knowledge of ISO13485 and FDA regulations, and strong English communication.

Qualifications

• Bachelor’s degree in life sciences preferred.
• Minimum 2 years of Regulatory Affairs experience.
• Strong knowledge of EU MDR, ISO13485 and FDA medical device regulations.
• Proficient in Microsoft Office.
• Excellent written and verbal English communication.

Responsibilities

• Collaborate with regulatory project team to review, update, and create Technical Documents (TDs) for EU MDR and other regulatory requirements.
• Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations.
• Draft, create or update TDs in collaboration with Platform RA SME.
• Review, obtain, and combine TF/DD documents into Adobe PDF files and upload bookmarks/indexes into PLM via Change Orders.
• Perform quality control checks for completeness, pagination, and presence of all pages.
• Coordinate with cross-functional teams and local affiliates to obtain supporting documents.

Skills

Regulatory Affairs

EU MDR

ISO 13485

FDA Regulations

Education

Bachelor's degree (life sciences preferred)

Job description

ClinChoice Canada Inc. is seeking a Sr. Regulatory Affairs Associate – CONSULTANT to join its global CRO team on a 12‑month contract.

You will work closely with regulatory project teams to review, draft, and manage Technical Documents for EU MDR and other regulatory needs, ensuring accuracy and timely delivery. The role requires at least 2 years in Regulatory Affairs focused on EU MDR, knowledge of ISO13485 and FDA regulations, and strong English communication.