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!
This role will support the RA Manager in achieving regulatory goals and objectives. In this position, you will work to proactively support the organization in achieving and maintaining the necessary regulatory clearances needed for targeted market areas. Additionally, you will provide an Elekta centre of competence and support for worldwide regulatory activities including those relating to the global governments (e.g. EU, US, Canada, Japan and China).
- Work on projects to completion with minimal supervision
- To lead the regulatory compliance planning, reporting and submission activities
- To facilitate standards compliance verification activities and standards compliance for Elekta products
- To provide regulatory intelligence for the production of applicable standards and their transition dates for Elekta products
- Conduct project planning and reporting meetings
- Develop process improvements at the project level
- Create and prioritize projects
- Commits to Quality - Adheres to and improves processes and work
- Drives change - Identifies, plans, and implements changes
- Provides creative solutions – Offers proposals and ideas to solve problems
- Liaise with external regulatory bodies and internal functions within Elekta
- Perform regulatory review of business documentation (e.g. Field change Orders, Marketing materials, application training, etc.).
- 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
- Degree equivalent in an Engineering or Science related subject or a formal engineering apprenticeship with demonstrated experience in a similar role preferred. Experience in medical device industry QA&RA in lieu of degree.
- Excellent interpersonal and communication skills, especially with technical personnel
- Proactive and solutions-orientated
- Ability to interpret, adapt and provide guidance on product regulation.
- Preferably knowledge and proven track record in RA
- Methodical thinker with ability to interpret regulatory requirements and apply in meaningful business requirements
- Experience in either Quality System or Manufacturing gained preferably within a medical device environment
- Proficient in computer applications e.g. Microsoft Office applications.
- Able to work within a multi-cultural environment.
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