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Sr. RA Associate Consultant- EU MDR
Contract type
Freelance
Work mode
Remote · Canada
Experience
Mid-level · 2+ years
Job description
A 12-month contract (with possible extension) as a Senior Regulatory Affairs Associate consultant, working directly for a single client sponsor through ClinChoice. The role focuses on reviewing, updating and creating Technical Documents in line with EU MDR and other medical device regulatory requirements.
At a glance
- Employment
- Contract · Independent contractor
- Work mode
- Remote · Canada
- Languages
- English – fluent
- Pay
- CAD 40 – 44 / hour
- Apply before
- November 21, 2026
What you'll do
- Establish and maintain an understanding of EU MDR and other global medical device 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 in PLM or similar regulatory sources into Adobe PDF files
- Create and upload bookmarks/indexes of the Adobe PDF files into PLM via Change Orders
- Perform Quality Control checks in accordance with client procedures, training, and checklists, including verification of completeness, correct pagination, and absence of blank or missing pages
- Verify TD documents are approved and contain the most recent revision(s)
- Work with the cross functional teams and Company's local affiliates to obtain necessary supporting documents
- Respond to inquiries from the Company's local affiliates and proactively notify and coordinate with cross-functional teams including management any health authority–related questions or requests
- Represent Regulatory Affairs on project teams and report regulatory requirements in the frequency, format, and sequence as required
- Attend meetings and communicate with the project team as appropriate
- Routinely communicate with regulatory management team regarding project status and deliverables
- Support other regulatory activities as assigned
What we're looking for
- Bachelor's degree (life sciences preferred)
- Minimum of 2 years of working experience in Regulatory Affairs focused on EU MDR
- Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations is mandatory
- Working proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint)
- Self-starter with ability to work in team environment and projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision
- Strong organizational skills including attention to detail, good planning and communication skills are required
- Strong written and verbal English communication skills required
How to get hired
- 1Submit CV and receive an acknowledgement
- 2Phone interview as the first step
- 3AI screening for keywords and minimum qualifications, with recruiters reviewing all results
Apply
About ClinChoice
Global full-service CRO
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
Mission
To contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices
Key facts
- over 4,000 professionals
- Contract Research Organization (CRO)
- Over 28 years of proven high-quality delivery and results across all our services
- Over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific
- Below industry average turnover rates
What they value
- Quality
- Professional development
- Supportive culture
- Diversity and inclusivity
- Continuous training