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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 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.
Able to work within a multi-cultural environment.
What we offer:
Opportunity to work with a proactive and supportive team
Excellent Medical, Dental and Vision coverage
401k, paid Vacation and Holiday
A health of additional benefits including wellness reimbursement, tuition reimbursement and flexible spending account
Opportunity to work on cutting edge in medical advancement
Close-knit company culture
Upward mobility
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.
