Regulatory Affairs Project Lead -Canada

Description

Job Description

• Regulatory Affairs Project Lead - Canada
• (This role is based in the US but will be focused on the Canadian Market)
• Salary Range: $70,000-$75,000, commensurate with experience

This position is on-site, full-time, located at our Corporate Headquarters in Buffalo Grove, IL

Corporate Headquarters

485 Half Day Rd. Ste 100

Buffalo Grove, IL 60089

Summary

The primary responsibility of the Regulatory Affairs Project Lead is to act as the primary point of contact, registrations and listings, and review for the Canadian Market and back-up for Regulatory Projects,

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Manage, Coordinate and collaborate with departments for complaint investigation
• Regulatory Administration
• LTD back-up contact for submissions, registrations / listings
• Back-up for consultants communication
• Labeling / submissions review- License amendments, faxbacks, MDEL, MDALL
• Clinical Education / Mkt reviews and routing
• Assist with submissions to the FDA and Health CA for medical devices
• Predicate searches for substantial equivalence table creation
• Manage new hire, annual trainings and effectiveness checks
• Co-Manage regulatory audits as scribe, or audit logistics personnel
• Analyze, review and design documents and checklists
• Maintain registrations and listings for the existing products in Canada
• Perform tasks to support the implementation of other Quality System elements as needed-Initial Warehouse / Depot Setup
• SOP and documentation management
• Record Keeping
• Change control / Documentation management
• Regulatory Intelligence / competitive analysis research
• Escalate challenges to resolve issues
• Report writing
• Presentation creation and delivery
• Metrics tracking
• Works very closely in the clinical, sales, and customer service, and field service on equipment as it pertains to direct patient care in CA

Competencies

• Initiative
• Problem Solving/Analysis
• Technical Capacity
• Organizational Skills
• Communication Proficiency
• Ability to retain large amounts of information

Education and Experience Required

• Bachelor’s degree or equivalent experience
• Experience in the FDA and Health Canada submissions and audits is required

Skills Required

• Positive attitude and approach to the job responsibilities and the Alma team
• Microsoft Applications (MS Office, Excel, PowerPoint, and Outlook)
• Excellent organizational skills
• Emotional Intelligence
• Ability to multitask
• Travel to and from Canadian Site- Quarterly

Supervisory Responsibility

This position has no direct reports but assists in mentoring peers and other departments as needed.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. You will be working with sensitive patient images.

Travel

This position requires approximately 15% travel as needed, with travel concentrated in Canada. 

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

Work Authorization

Documentation showing eligibility to work in the United States will be required.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Alma, Inc. is Equal Opportunity Employment:

We're proud to be an equal opportunity employer and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status.

E-Verification:

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Requirements

None