Regulatory Affairs Project Lead - 247670

Medix™; Buffalo Grove (IL); On-site; USD 75,000 - 90,000; Full time

Job summary

A leading healthcare consultancy is seeking a Regulatory Affairs Project Lead in Buffalo Grove, IL. The role involves managing regulatory submissions and collaborating with various teams to ensure compliance, particularly in the Canadian market. Candidates should have experience with FDA and Health Canada processes, a valid US passport, and strong organizational skills. This position offers a direct hire employment with a salary range of $75,000-$90,000, onsite from Monday to Friday.

Qualifications

• Experience in FDA and Health Canada submissions and audits is required.
• Valid US Passport.

Responsibilities

• Manage, coordinate, and collaborate with departments for complaint investigation.
• Assist with submissions to the FDA and Health Canada for medical devices.
• Conduct regulatory intelligence and competitive analysis research.

Skills

Proficiency in Microsoft Applications (MS Office, Excel, PowerPoint, Outlook)

Excellent organizational skills

Ability to multitask

Positive attitude and approach to job responsibilities

Education

Bachelor’s or Associate's degree or equivalent experience in Medical Device industry

Job description

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.

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