Job Description

Regulatory Affairs Project Lead

Job Summary

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.

Key Responsibilities

• 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
• Track metrics
• Collaborate with clinical, sales, customer service, and field service teams regarding equipment for direct patient care in Canada

Qualifications

• 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

Skills

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

Additional Requirements

Travel to and from the Canadian site is required quarterly.

Location: Buffalo Grove, IL

Structure: Onsite Monday-Friday

(potential for earned hybrid structure)

Employment Type: Direct Hire

Pay: $75,000-$90,000

Hours: Monday-Friday 8AM-4PM

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