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 main responsibility of the Senior Regulatory Affairs Engineer is to support the RA North America organization in achieving regulatory goals and objectives and proactively support the organization in achieving and maintaining the necessary regulatory clearances needed for the US and Canada. The selected candidate will provide support for regulatory activities with the US FDA and Health Canada.
This position is based in the office located in St. Charles, MO. We will also consider remote candidates within the same time zone.
- 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 produce applicable US FDA and HC standards and their transition dates for Elekta products.
- Provide the regulatory support to the US and Canada Commercial groups.
- Ensure the regulatory compliance of the US and Canada establishments.
- 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
- 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. Field change Orders, Marketing material, 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
- 5+ years of regulatory experience on class II and III Medical devices in the US and Canadian
- RAC certification
- 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 Regulatory Affairs
- Engineering or other related areas qualifications
- Methodical thinker with ability to interpret regulatory requirements and apply in meaningful business requirements
- Must be able to travel up to 15 % 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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