Senior Regulatory Affairs Specialist
Radformation creates solutions that detect medical errors and save clinical time for clinicians with a focus in radiation therapy. Using advanced algorithms and optimization techniques, our solutions bring automation to cancer treatments. Currently, many safety checks and planning steps are manually completed. Our goal is to help automate these processes for a more efficient and safer healthcare environment.
Our software focuses on three key areas:
- Increased quality care through advanced algorithms creating patient treatment plans that are improved from current manual methods.
- Error reduction through automated systems monitoring patients for errors.
- Time savings through automation.
Radformation is a growing company with an expanding customer base in North America. With a reputation of creating practical tools for the clinic, Radformation is expanding its network globally.
We are looking for a highly motivated individual who has a passion for regulatory affairs, learning new technologies, and researching market needs. The Senior Regulatory Affairs Specialist will be a key team member managing FDA 510(k) submissions and our quality management system. The ideal candidate has worked in radiation oncology, successfully submitted FDA 510(k) applications, and has a strong understanding of quality management systems. This is an opportunity to be a part of a fast-growing startup helping cancer patients around the world.If you consider yourself organized, flexible, and a great multitasker with strong communication skills, we hope you’ll apply to this position. Responsibilities include:
- Prepare FDA 510(k) submissions
- Prepare CE marking submissions
- Work with regulatory agencies around the world to achieve medical device clearance
- Manage quality managment system and comply with ISO 13485
- Ensure compliance with regulations
- Explain regulations, policies, or procedures
- Provide technical review of data and reports
- Coordinate regulatory documentation activities
- 5+ years of regulatory affairs
- Experience working in radiation oncology or related field
- Experience with FDA 510(k) process
- Experience with CE marking process
- Experience with global regulatory agencies
- Experience with Quality Management Systems and ISO 13485
- Highly motivated
- Strong analytical skills
- Passionate about learning
- Excellent communication and interpersonal skills
- The ability to think strategically, multi-task, and meet deadlines
- The ability to research numerous markets and develop an understanding of and articulate the nuances between segments
- Competitive salary
- Immediate Health/Vision/Dental insurance
- Roth 401(k)
- Paid Time Off
- Stock options
For more information or to apply please contact us at firstname.lastname@example.org