Senior Regulatory Affairs Consultant – EU MDR Contract

Clinchoice; Burnaby; Remote; CAD 55,000 - 61,000; Part time

Job summary

ClinChoice is seeking a Sr. Regulatory Affairs Associate – CONSULTANT for a 12-month contract in Canada. The role collaborates with the regulatory team to manage TDs per EU MDR and other regulatory requirements, with duties spanning document creation, QA, and cross-functional coordination.

The ideal candidate has a life sciences degree and 2+ years in EU MDR regulatory affairs, plus strong English communication and MS Office skills. Remote/contract arrangements are indicated.

Qualifications

• Bachelor’s degree in life sciences preferred.
• Minimum 2 years of Regulatory Affairs experience on EU MDR.
• Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations.

Responsibilities

• Review, update, and create Technical Documents (TDs) per EU MDR and global requirements.
• Identify applicable regulatory requirements, standards, guidance, and submission expectations.
• Draft or update TDs in collaboration with RA SME.
• Review and assemble TF/DD documents into PDF files and organize in PLM.
• Perform QC checks for completeness, pagination, and revision accuracy.
• Coordinate with cross-functional teams to obtain supporting documents.
• Respond to inquiries from local affiliates and relay regulatory questions to teams.
• Represent Regulatory Affairs on project teams and report status and deliverables.

Skills

EU MDR knowledge

Regulatory affairs experience

English communication

Education

Bachelor’s degree in life sciences

Tools

Microsoft Office

Job description

ClinChoice is seeking a Sr. Regulatory Affairs Associate – CONSULTANT for a 12-month contract in Canada. The role collaborates with the regulatory team to manage TDs per EU MDR and other regulatory requirements, with duties spanning document creation, QA, and cross-functional coordination.

The ideal candidate has a life sciences degree and 2+ years in EU MDR regulatory affairs, plus strong English communication and MS Office skills. Remote/contract arrangements are indicated.