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
Job Tags
Monday to Friday,