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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!

Preferred Location: Sandy Springs, GA Office-Based (Hybrid)

Description

The Manager Regulatory Affairs & Quality Americas has responsibility for supervising people and functions that support the directions and initiatives defined for the department. 

The Manager Regulatory Affairs & Quality Americas have responsibility for setting priorities and expectations among their direct reports and monitoring/reporting on budget, planning and logistics.

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.

• Issue and change processes and procedures.

• Deploys and implements Elekta Quality Policy and other directives and processes as applicable to the region.

Authorities:

• Execution of global & local RA and Q strategies and policies as defined in the departmental business plan.

• Approve requests for function expenses incurred at a local level within the business guidelines.

• To blockade any necessary devices that do not possess the adequate regulatory status required for shipment.

• Authorisation of absence, sickness and holidays for direct reports

• Performing GPMs and setting of development plans for direct reports

• The Manager will be asked to authorize documents and forms whilst carrying out their responsibilities.

• Sign off and release of regulatory documentation to governing agencies

• Approves changes to the quality management system under their responsibility.

• Manage departmental budgets as applicable.

• Deputise for direct manager

Qualifications:

• Professional integrity with an ability to lead the interpretation of product regulation and translate into meaningful business requirements.

• Objective driven and customer focused, with an ability to influence people.

• Capable of leading teams to deliver desired results.

• A structured approach to problem solving with an appreciation of quality tools & techniques.

• An effective team player who can mentor and lead problem solving to provide solutions to the business.

• Confident and open personality who is able to communicate effectively, both written and orally with people at all levels.

• A positive attitude towards change to promote the global goals of the business.

• Knowledge and proven track record in Regulatory Affairs for Medical Devices.

• Knowledge of r