Job Description

Regulatory Affairs Manager

Job Summary

Our client is seeking a Regulatory Affairs Manager whose primary responsibility will be to act as the main point of contact for registrations and listings, particularly focusing on the Canadian market. The role also includes reviewing regulatory projects as a backup.

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

• Bachelors 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: Contract to Hire

Pay: $34-38/hour

Hours: Monday-Friday 8AM-4PM

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