Regulatory Affairs Project Lead

Regulatory Affairs Project Lead - 247670

Our client is seeking a Regulatory Affairs Project Lead whose primary responsibility will be to act as the main point of contact for registrations and listings, particularly focusing on the Canadian market.

• Manage, coordinate, and collaborate with departments for complaint investigation
• Regulatory Administration
• Serve as LTD back‑up contact for submissions, registrations, and listings
• Back‑up for consultants communication
• Evaluate labeling and submissions for license amendments, faxbacks, MDEL, and MDALL
• Participate in clinical education and marketing reviews and routing
• Assist with submissions to the FDA and Health Canada for medical devices
• Conduct predicate searches for substantial equivalence table creation
• Co‑manage regulatory audits as scribe or audit logistics personnel
• Analyze, review, and design documents and checklists
• Maintain registrations and listings for existing products in Canada
• Support the implementation of other Quality System elements as needed
• Oversee SOP and documentation management
• Handle record‑keeping
• Manage change control and documentation
• Conduct regulatory intelligence and competitive analysis research
• Escalate challenges to resolve issues
• Generate report writing and presentation creation and delivery
• Collaborate with clinical, sales, customer service, and field service teams regarding equipment for direct patient care in Canada

• Bachelor’s or Associate's degree or equivalent experience in Medical Device industry
• Experience in FDA and Health Canada submissions and audits is required
• Valid US Passport

• Proficiency in Microsoft Applications (MS Office, Excel, PowerPoint, Outlook)
• Excellent organizational skills
• Ability to multitask
• Positive attitude and approach to job responsibilities

Travel to and from the Canadian site is required quarterly.

Onsite Monday-Friday

(potential for earned hybrid structure)

Direct Hire

$75,000-$90,000

Monday-Friday 8AM-4PM