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!
The Regulatory Affairs Software Manager has responsibility for supervising people and functions that support the directions and initiatives defined for the department. The Regulatory Software Manager has responsibility for setting priorities and expectations among their direct reports and monitoring/reporting on budget, planning and logistics.
This position is primarily based in the office located in St. Charles, MO. We will also consider remote candidates within the same time zone. Frequent travel to the St. Charles, MO is a requirement for remote candidates.
- Implement and execute global RA strategies and policies as appropriate to the local quality system.
- Represent the RA Group position on regulatory or quality matters, as directed by Global RA management.
- 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
- Coordinator for Regulatory Submissions for applicable Elekta Groups
- 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.
- Be Elekta's representative 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.
- Support locally appointed regulatory staff in respective areas in their interactions with national authorities and in preparations of submissions and compliance data.
- Responsible for the creation and maintenance of the Continuous Learning within Global Regulatory Affairs.
- Blockade any necessary devices that do not possess the adequate regulatory status required for shipment.
- 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
- 8+ years of regulatory experience on class II and III Medical devices in the US and Canadian
- RAC certification
- 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.
- Be able to 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 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.
- Must be able to travel up to 40% of the time
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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