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    Regulatory Affairs Coordinator - Burlington, Canada - Straumann Group

    Straumann Group
    Straumann Group Burlington, Canada

    2 weeks ago

    Default job background
    Full time
    Description

    Position Summary

    This position is responsible for performing tasks that ensure Straumann complies with United States and Canadian regulations for the handling and management of complaints and adverse event reporting. Responsibilities include documenting, processing, and closing of customer complaints. This position is also responsible for maintaining positive customer relationships while maintaining compliance with company policies. This position is responsible for supporting the quality system (CAPA program, NCMRs, etc.) and acts as the representative for Straumann Canada with respect to the Quality System and Regulatory Affairs functions as the liaison to Health Canada.

    Job Responsibilities
    This position is responsible for, but not limited to, the following:

  • Overall administration of Straumann Canada's complaint activities
  • Document complaints in the complaint management system
  • Communicate with external and internal customers via the regulatory telephone queue and department email inbox.
  • Interact with customers to resolve complaints according to company policy and applicable regulations
  • Process incoming complaint product shipments (i.e., open and process mail) with possible exposure to bloodborne pathogens
  • Review complaints to determine whether regulatory authority reporting and/or assessment by the Product Safety Officer is warranted
  • Supervise complaint shipment to the Designated Complaint Handling Unit (DCHU)
  • Review complaint analysis reports and close out customer complaints according to applicable regulatory requirements and company policies and procedures
  • Coordination of complaint handling with NAM Regulatory Affairs group
  • Motivate and lead the Canadian Complaint team from a Subject Matter Expert (SME) perspective
  • Coach, develop, and monitor the Canadian Complaint team performance through quality review and feedback of complaints and customer communications
  • Handle challenging and escalated customer issues to resolution
  • Training and on-boarding of new hires
  • Development and continuous improvement of department processes and procedures
  • Act as the Complaint Management SME during audits/inspections
  • Maintain excellent working knowledge of company's products
  • Overall administration of Straumann Canada's quality activities
  • Acts as a liaison between Straumann Canada and Health Canada
  • Act as the scientific director for Straumann Canada's Tissue Bank operations
  • Coordinates the filing of required documentation to Health Canada
  • Coordinates recall activity affecting the Canadian market
  • Assists with product quarantine and incoming inspections
  • Conducts regulatory review of new 3rd party products in Canada
  • Maintains local regulatory files (Mandatory Problem Reports, Recalls, and Product Licenses)
  • Maintains local Quality System documentation (procedures, complaints, CAPA's, audit reports, NCMR's, product quarantine, and release records)
  • Supports the review and approval of Straumann Canada's procedures
  • Supports the administration of CAPAs, NCMRs, and assists in document control
  • Assist in training personnel where applicable
  • Participates in Health Canada inspections and other third-party audits

    • Minimum Qualifications

  • High School Diploma or GED required
  • 3+ years prior dental and/or complaint handling experience
  • 1+ year of basic computer skills including Microsoft Office

    • Preferred Qualifications

  • Advanced degree
  • Experience working in a regulated industry
  • Basic knowledge of SAP
  • Excellent organizational skills with strong attention to detail and the ability to multi-task effectively
  • Strong record of reliability with demonstrated follow through
  • Excellent written and oral communication skills
  • Leadership aptitude and potential
  • Strong decision-making and problem-solving skills with sound judgement

    • Whether you're looking to build your career, improve your health, or brighten your SMILE, we offer generous benefits to help you achieve your goals.

  • Very Competitive total compensation plans (some positions include discretionary bonus, or Performance Share Units).
  • A 401(K) plan to help you plan for your future with an employer match
  • Great health, dental and vision insurance packages to fit your needs to ensure you're happy and healthy. Straumann contributes a healthy portion towards employees' premium.
  • Generous PTO allowance - plenty of time to recharge those batteries
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