Regulatory Affairs Specialist - R2024-1511
Elekta Inc. - Atlanta, GA
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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 dont 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 supervision To 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 manufacturers To provide regulatory intelligence to product teams and facilitate compliance and transition to new standards/ regulations Provide 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 stakeholders Conduct project planning and reporting meetings Assist in process improvements objectives Create and prioritize projects 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 Liaise with external regulatory bodies and internal functions within Elekta To 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 globally Professional and reliable Excellent interpersonal and communication skills, especially with technical personnel Proactive and solutions-orientated Computer literate with a basic knowledge of file management and networking Ability to interpret, adapt and provide guidance on product regulation. Preferably knowledge and proven track record in RA Engineering or other related areas qualifications Methodical thinker with ability to interpret regulatory requirements and apply in meaningful business requirements What youll 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 team Hybrid work option (you are required to work on location at least 3 days/week) 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 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 otherprotected characteristic. Here at E ekta, 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. Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
Created: 2024-09-20