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The Research and Development team at Foundation Medicine is constantly pushing the envelope to transform cancer care.

Watch the video to see how each member has the chance to make a real impact. 

 

Co-Op, Regulatory Affairs (Graduate)

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Co-op, 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 Co-op assists with preparation of document packages for Health Authority and Regulatory Bodies and ensures compliance with all requirements. 

Key Responsibilities

• Creates, assembles and publishes documents and builds Regulatory submission deliverables and ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.

• Provides guidance on good documentation and submission practices to project teams.

• Performs 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 (categorizing and classifying information) all Regulatory records pertaining to multiple Regulatory Applications (e.g., Pre-Submissions, IDE, PMA), maintaining Regulatory Application indexes, tracking of regulatory submission documents, and special projects as needed.

• Assists 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.

• Tracks departmental metrics and metrics associated with submission publishing and rework.

• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree in science, engineering, health policy, or regulatory affairs

• Currently enrolled in a Master's of PhD program studying regulatory affairs, life science or engineering

Preferred Qualifications

• Ability to comprehend principles of science, engineering, physiology and medical device use

• Experience in oncology, NGS, IVD, CAP/CLIA, and/or regulatory

• Ability to comprehend principles of science, engineering, physiology and medical device use

• Experience in oncology, NGS, IVD, CAP/CLIA, and/or regulatory

• Familiarity with device design control process· Experience with interpreting and applying FDA guidance and regulations

• Experience interfacing with the FDA (e.g., CDRH), including submissions (e.g., SRDs, IDEs, PMAs) and Pre-Submission meetings

• Excellent oral and written communication and negotiation skills with strong attention to detail and clarity

• Ability to prepare and present information to groups

• Ability to interact effectively across relevant functions

• Recognized as a team player and possess a cross-functional collaborative skill set

• Strong organizational skills and attention to detail

• Ability to work in a fast-paced/entrepreneurial environment

• High degree of initiative with the ability to work independently

• Understanding of HIPAA and importance of patient data privacy

• Commitment to reflect FMI’s values: passion, patients, innovation and collaboration

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