About the Job
The Intern, Regulatory Affairs supports the regulatory submissions process through development of regulatory strategy and submission of materials to Health Authorities and Regulatory Bodies (e.g., FDA) for approval of novel platforms. The intern assists with preparation of document packages for Health Authority and Regulatory Bodies and ensures compliance with all requirements.
The FMI Internship Program is offered to students currently registered in a degree program. It is a 10-12 week summer commitment, Full Time, 40 hours/week. Interns will gain a greater understanding of FMI through challenging project-based work, Spotlight Speaker Series with company executives, and the chance to connect with all employees by attending many company-wide events.
This team is currently working remotely, but when working in office is based in Cambridge, MA.
• Create, assemble and publish documents and build Regulatory submission deliverables and ensure quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.
• Provide guidance on good documentation and submission practices to project teams.
• Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances.
• Assist in implementation of FDA compliant (QSR) and ISO 13485 Quality System.
• Archive (categorize and classify information) all Regulatory records pertaining to multiple Regulatory Applications (e.g., Pre-Submissions, IDE, PMA), maintain Regulatory Application indexes, track regulatory submission documents, and special projects as needed.
• Assist in tracking routine submission schedules.
• Assist in developing and creating standard operating procedures (SOPs) for the Regulatory Affairs Team.
• Assist in developing templates and standardized documentation for various types of regulated submissions.
• Track departmental metrics and metrics associated with submission publishing and rework.
• Other duties as assigned.
• Bachelor’s Degree in science, engineering, health policy, regulatory affairs or related field of study
• Currently enrolled in a Master's or PhD program studying regulatory affairs, biology, molecular biology, public health, life science, engineering or related field of study
• Experience in oncology, NGS, IVD, CAP/CLIA, and/or regulatory
• Experience interfacing with the FDA (e.g., CDRH), including submissions (e.g., SRDs, IDEs, PMAs) and Pre-Submission meetings
• Experience with interpreting and applying FDA guidance and regulations
• Familiarity with device design control process
• Ability to comprehend principles of science, engineering, physiology and medical device use
• Ability to prepare and present information to groups
• Ability to interact effectively across relevant functions
• Ability to work in a fast-paced/entrepreneurial environment
• Ability to work independently
• Ability to work on a team with a cross-functional collaborative skill set
• Excellent oral and written communication and negotiation skills with strong attention to detail and clarity
• Strong organizational skills and attention to detail
• Understanding of HIPAA and importance of patient data privacy
• Commitment to reflect FMI’s values: Patients, Passion, Innovation and Collaboration
Internal applicants, please use your FMI email address.
Foundation Medicine’s commitment to bringing positive learning experiences to students through our Internship Program has not changed in light of Covid-19 restrictions. We have moved our 2021 program to be a virtual one, and are continuing to provide meaningful work to university students. If selected to participate in our virtual Internship Program, you will be given challenging work, robust networking opportunities, and many ways to experience Foundation Medicine’s culture. While we anxiously await the time when we are all able to be together again, we will not let this slow us down. At Foundation Medicine, we are driven to bring our best to patients every day and we look forward to working with the brightest minds.