About this opportunity
Medix™ lists this Regulatory Affairs Project Lead - 247670 opportunity in buffalo grove, Illinois. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Regulatory Affairs Project Lead -
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
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
Ability to multitask
Positive attitude and approach to job responsibilities
Additional Requirements
Travel to and from the Canadian site is required quarterly.
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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Worksite address
buffalo grove, IL, 60089, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.