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Regulatory Affairs Principal

Radformation

Radformation

Legal
United States · Remote
Posted on Wednesday, July 3, 2024
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.

Responsibilities

  • Develop sound global, regional, and multi-country regulatory strategies for new and modified SaMD medical devices.
  • Provide regulatory intelligence to aid in market assessments and portfolio planning
  • Prepare international and domestic submissions/registrations to established timelines and company objectives (e.g.,510(k), Q-submissions, Technical Documentations)
  • Represent Regulatory Affairs on assigned projects and provide regulatory guidance to the cross-functional teams
  • Collaborate with cross functional partners in driving and implementing new processes to address non conformances or remediation efforts.
  • Anticipate regulatory and related obstacles and emerging issues throughout the product life cycle
  • Interact with regulatory authorities during the development and review process to ensure submission approval
  • Defining regulatory requirements on device labeling and review labeling content for compliance for global markets
  • Coordinate with international contacts on product changes, regulatory notifications and registration/license maintenance
  • Review and approve product design changes to maintain regulatory compliance for significant changes
  • Author or revise SOPs to improve regulatory compliance of the Quality System
  • Monitor impact of changing global regulations on submission strategies & registrations
  • Perform other quality and regulatory-related duties as assigned.

Abilities

  • Excellent command of the English language (written and oral).
  • Excellent attention to detail and quality as well as excellent editorial/proofreading skills
  • Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
  • Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
  • Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
  • Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
  • Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
  • Excellent analytical, investigative and problem-solving skills
  • Experience with Quality System Management, Development and Improvement

Required Experience

  • >8 years of regulatory affairs experience with a Bachelor's degree (B.A./B.S. required); >6 years experience with Master's or other advanced degree in a related field
  • Lead and/or author 510k or MDR submission experience required
  • Familiarity with global medical device regulations; 21 CFR 820, MDD/CMDR, EU MDR, ASIA PAC, LATAM, etc.
  • Demonstrated understanding of ISO 13485, ISO 14971, GDPR, HIPAA and other international regulations/directives/standards
  • Exceptional communication (written and oral) skills - Experience writing content for regulatory submissions. (CER\CEP\Tech Papers\Reports\RBA…)
  • Willingness to travel when required, up to 5% (Audit Support)
  • Cross Skilled in QMS
  • Completing Regulatory Impact Assessments

Preferred Experience

  • Software as a medical device (SaMD) experience highly preferred
  • Product development experience highly preferred
  • Strong project management skills
  • Risk Management Processes and Deliverables
  • Post Market \ Adverse Event Evaluation and Reporting
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 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.