Elekta Job - 30953926 | CareerArc
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Company: Elekta
Location: Atlanta, GA
Career Level: Director
Industries: Healthcare, Pharmaceutical, Biotech

Description

Want to join a team with a mission to improve and save lives?

We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their communities.

We currently have the following opportunity available - please contact us for more details!

Summary:

The Director of Regulatory Affairs & Quality Americas is a senior management position responsible for the strategic and tactical management of the Regulatory Affairs & Quality Americas groups.

Responsibilities:

  • Drives activities with a sense of the overall mission
  • Actively participates in defining the vision for the department
  • Set organization goals, in collaboration with partner organizations and managers
  • Define the direction of change
  • Commits to Quality - Adheres to and improves processes and work
  • Drives change - Identifies, plans, and implements changes
  • Demonstrates integrity - Positive relationships and honest dependable results
  • Provides creative solutions – Offers proposals and ideas to solve problems
  • Demonstrates leadership through:
    • Delivers results
    • Aligns priorities
    • Develops teams
    • Manages change
  • Regional Coordinator for Regulatory Submissions and Regulatory Strategies. Inform local organizations about changes in legislations, support local organizations with interpretation of legislations and advice about strategies.
  • Support, create and maintain the Regional Submission Process(s) and Regulatory Roadmap.
  • Manage and coordinate the Regional Submission Area.
  • Be Elekta's representative in the region in interactions with international bodies in the field of regulatory submissions with a potential to have an impact on Elekta's businesses,
  • Participate/report to management review regarding all Elekta regulatory submissions and quality system.
  • Support locally appointed regulatory and quality staff in respective areas in their interactions with national authorities and in preparations of submissions and compliance data.

We offer:

  • Excellent Medical, Dental, and Vision coverage
  • 401k, paid Vacation and Holiday
  • A wealth of additional benefits including Wellness Reimbursement, Tuition Reimbursement and Flexible Spending Account
  • Opportunity to work in the cutting edge in medical advancement
  • Close knit company culture
  • Upward mobility

Qualifications:

  • Knowledge and proven track record in Regulatory Affairs for Medical Devices.
  • Knowledge of region regulations.
  • Knowledge in either Supplier Quality, Quality or Manufacturing Engineering, gained preferably within a medical device environment.
  • Preferably an experienced ISO Auditor
  • Knowledge of the European Directive for Medical Devices and US FDA regulations would be an advantage.
  • Proficient in Microsoft Office applications
  • Degree equivalent in an Engineering related subject or a formal Engineering apprenticeship with demonstrated experience in a similar role.
  • Availability for international travel required

EEO Statement

We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, disability, veteran status, or any other protected characteristic.


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