Sr. Regulatory Affairs Specialist

Remote US /
Regulatory – Regulatory /
Full-Time
/ Remote
Work at Radformation

Cancer rates increase year after year, yet high-quality care is not universal. By automating and standardizing the treatment planning workflow, Radformation aims to create a system where any patient anywhere can receive the same high-quality care.

We strive daily to reduce cancer's global impact and help save more of the 10 million lives it claims each year. Our unwavering commitment is to deliver reliable, high-quality, automated solutions that allow clinics to standardized care for every single person in need.

Radformation is seeking a self-motivated Regulatory Affairs Senior Specialist to join an innovative team. As Radformation sets out to scale, the Regulatory Affairs Senior Specialist will work directly with the Director of Regulatory Affairs to:

·       Develop and execute regulatory strategies
·       Improve the internal quality management system and regulatory processes
·       Compiles regulatory submissions
·       Provide support to currently marketed products as necessary.  
 
Regulatory Affairs is a multidimensional discipline. As part of a smaller team environment, you will have the opportunity to learn and work through all aspects of the Regulatory profession and not be siloed into any particular process, thus making you highly marketable in your career. We require that you are coachable and have the drive to become a leader in the Regulatory profession.   

Responsibilities

    • Preparation of Regulatory submissions and Technical Documents.
    • Work with our Internal stakeholders and teams to guide completion product technical documentations. 
    • Work with regulatory agencies and partners worldwide to achieve market access and compliance. 
    • Ensure compliance with regulations.
    • Explain regulations, policies, or procedures.
    • Provide technical review of data and reports.

Abilities

    • Highly motivated
    • 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

Required Experience

    • MS in Regulatory Affairs or RAC Certified (Medical Devices)
    • 5+ years of regulatory affairs experience
    • Experience with Technical Documentations and Regulatory Submissions. 
    • Experience with ISO 13485, ISO 14971, IEC 62304, and IEC 62366-1
    • Experience with Radiation Oncology is a big plus

Salary

    • $100k-$110k, dependent on experience
What makes us so RAD?

We take care of our people!

Radformation offers top-tier medical, dental, vision care for employees and their families. Each role comes with stock options, our 401(k) & employer match vest immediately and you'll never have to stress about taking the time you need with self-managed PTO. We support our growing RAD families with generous parental leave, along with additional part-time work to help transition back into the swing of things. We are a fully remote team and while we may be apart, virtual events, yearly retreats and a collaborative work environment keep us close and connected.

Cancer transcends any individual differences we may have. That's why at Radformation we celebrate diversity and are committed to creating an inclusive environment for all employees. We are proud to be an equal opportunity workplace and an affirmative action employer.