Regulatory Affairs Project Lead - 247670 Job at Medix™, Buffalo Grove, IL

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  • Medix™
  • Buffalo Grove, IL

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,

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