Elekta
Regulatory Affairs Specialist
Elekta, Atlanta, Georgia, United States, 30383
Are you a current Elekta employee?
Please click here to apply through our internal career site Find Jobs - Elekta.
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!
We don't just build technology. We build hope for everyone dealing with cancer.
The main responsibility of the Regulatory Affairs Specialist is to support the RA - Software organization in achieving regulatory goals and objectives and proactively support the organization in achieving and maintaining the necessary regulatory clearances needed globally.
Responsibilities:Work on projects to completion with manager supervisionTo lead the regulatory compliance planning, reporting and submission activities.To facilitate standards compliance verification activities and standards compliance for Elekta products and where applicable third-party manufacturersTo provide regulatory intelligence to product teams and facilitate compliance and transition to new standards/ regulationsProvide the regulatory support to software development teams by performing submission evaluations according to health authority change guidances, identifying appropriate standards, authoring submission documentation and communication with internal and external stakeholdersConduct project planning and reporting meetingsAssist in process improvements objectivesCreate and prioritize projectsCommits to Quality - Adheres to and improves processes and workDrives change - Identifies, plans, and implements changesDemonstrates integrity - Positive relationships and honest dependable resultsProvides creative solutions - Offers proposals and ideas to solve problemsLiaise with external regulatory bodies and internal functions within ElektaTo perform regulatory review of business documentation e.g. Product labeling, Field change Orders, Marketing material, application training etc.Travel: Must be able to travel up to 15 % of the time.What you bring
3+ years of regulatory experience on class II and III Medical devices globallyProfessional and reliableExcellent interpersonal and communication skills, especially with technical personnelProactive and solutions-orientatedComputer literate with a basic knowledge of file management and networkingAbility to interpret, adapt and provide guidance on product regulation.Preferably knowledge and proven track record in RAEngineering or other related areas qualificationsMethodical thinker with ability to interpret regulatory requirements and apply in meaningful business requirementsWhat you'll get
In this role, you will work for a higher purpose; hope for everyone dealing with cancer, and for everyone regardless of where in the world, to have access to the best cancer care. In addition to this, Elekta offers a range of benefits.
What we offer:
Opportunity to work with a proactive and supportive teamHybrid work option (you are required to work on location at least 3 days/week)Excellent Medical, Dental and Vision coverage401k, paid Vacation and HolidayA health of additional benefits including wellness reimbursement, tuition reimbursement and flexible spending accountOpportunity to work on cutting edge in medical advancement.Close-knit company cultureUpward mobility
How to proceed?
We are looking forward to hearing from you! Apply by submitting your application and rsum in English, via the "Apply" button. Please note that we do not accept applications by e-mail.
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.
Here at Elekta, you will make a difference. We are a MedTech company that provides software and hardware to hospitals and clinics all over the world.
We have a responsibility toward our partners and customers to deliver solutions in a secure and sustainable way. Both when it comes to financial and environmental matters, but also for our employees to feel that they bring value, wherever in the organization they may work.
Please click here to apply through our internal career site Find Jobs - Elekta.
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!
We don't just build technology. We build hope for everyone dealing with cancer.
The main responsibility of the Regulatory Affairs Specialist is to support the RA - Software organization in achieving regulatory goals and objectives and proactively support the organization in achieving and maintaining the necessary regulatory clearances needed globally.
Responsibilities:Work on projects to completion with manager supervisionTo lead the regulatory compliance planning, reporting and submission activities.To facilitate standards compliance verification activities and standards compliance for Elekta products and where applicable third-party manufacturersTo provide regulatory intelligence to product teams and facilitate compliance and transition to new standards/ regulationsProvide the regulatory support to software development teams by performing submission evaluations according to health authority change guidances, identifying appropriate standards, authoring submission documentation and communication with internal and external stakeholdersConduct project planning and reporting meetingsAssist in process improvements objectivesCreate and prioritize projectsCommits to Quality - Adheres to and improves processes and workDrives change - Identifies, plans, and implements changesDemonstrates integrity - Positive relationships and honest dependable resultsProvides creative solutions - Offers proposals and ideas to solve problemsLiaise with external regulatory bodies and internal functions within ElektaTo perform regulatory review of business documentation e.g. Product labeling, Field change Orders, Marketing material, application training etc.Travel: Must be able to travel up to 15 % of the time.What you bring
3+ years of regulatory experience on class II and III Medical devices globallyProfessional and reliableExcellent interpersonal and communication skills, especially with technical personnelProactive and solutions-orientatedComputer literate with a basic knowledge of file management and networkingAbility to interpret, adapt and provide guidance on product regulation.Preferably knowledge and proven track record in RAEngineering or other related areas qualificationsMethodical thinker with ability to interpret regulatory requirements and apply in meaningful business requirementsWhat you'll get
In this role, you will work for a higher purpose; hope for everyone dealing with cancer, and for everyone regardless of where in the world, to have access to the best cancer care. In addition to this, Elekta offers a range of benefits.
What we offer:
Opportunity to work with a proactive and supportive teamHybrid work option (you are required to work on location at least 3 days/week)Excellent Medical, Dental and Vision coverage401k, paid Vacation and HolidayA health of additional benefits including wellness reimbursement, tuition reimbursement and flexible spending accountOpportunity to work on cutting edge in medical advancement.Close-knit company cultureUpward mobility
How to proceed?
We are looking forward to hearing from you! Apply by submitting your application and rsum in English, via the "Apply" button. Please note that we do not accept applications by e-mail.
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.
Here at Elekta, you will make a difference. We are a MedTech company that provides software and hardware to hospitals and clinics all over the world.
We have a responsibility toward our partners and customers to deliver solutions in a secure and sustainable way. Both when it comes to financial and environmental matters, but also for our employees to feel that they bring value, wherever in the organization they may work.