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About the Job
The Regulatory Affairs Specialist performs activities to support the regulatory submissions process through development of regulatory strategy and submission of materials to the FDA for approval of novel platforms. The position prepares document packages for FDA or other US regulatory body agencies and ensures compliance with all requirements.
• Represent the regulatory affairs function on assigned cross-functional project teams.
• Assist in activities associated with regulatory approval of in vitro companion diagnostic medical devices in the US market.
• Write, prepare, edit and review FDA submissions using templates to expand indications of currently marketed products; documents including, but not limited to:
• Support and eventually manage interactions with regulatory agencies including responses to regulatory inspections and regulatory submissions.
• Support companion diagnostic regulatory strategy (analytical and clinical validation) and regulatory filings.
• Review validation protocols and reports for regulatory submission soundness.
• Publish electronic regulatory submissions.
• Represent FMI before regulatory authorities and biopharmaceutical partners on regulatory and technical matters, as needed.
• Provide support for marketed products, e.g., review engineering changes, labeling, promotional material, and product changes for compliance.
• Support change control activities that require regulatory agency approval per US regulatory requirements.
• Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the discipline as relevant to assigned projects.
• Draft submission documents with other subject matter experts as needed.
• Review and edit technical documents to be included in submission, which may include software validation protocols and reports and/or other software development documentation.
• Other duties as assigned.
• Bachelor’s Degree and 2+ years of professional experience in device, biotechnology, life science or healthcare regulatory affairs - OR - Advanced Degree (Master's Degree or higher) without experience
• Regulatory compliance knowledge of FDA IVD requirements and understanding of validation design typical for FDA IVD submissions
• Familiarity with device design control process and regulatory role in process
• Direct experience working with the Center for Devices and Radiological Health (CDRH) including writing and submitting pre-sub, IDE application and/or PMA documents to FDA CDRH
• Professional and/or academic experience:
• Experience with companion diagnostics
• Expertise in regulatory strategy
• Outstanding interpersonal skills that include excellence in written communication, oral communication, negotiation, collaboration and problem-solving
• Strong attention to detail and organizational skills
• Understanding of HIPAA and importance of patient data privacy
• Commitment to reflect FMI’s values: passion, patients, innovation and collaboration
#LI-Remote [Cambridge, Massachusetts, United States]
Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.
Internal applicants, please use your FMI email address.
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Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)
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