Associate Director, Regulatory Affairs - Diagnostics Industry

Organization
Foundation Medicine
Job Location
150 Second Street
Cambridge, MA 02141
Salary
Competitive
Job Description

Foundation Medicine is seeking an Associate Director, Regulatory Affairs. This position will assist with Regulatory Affairs activities by writing and editing technical documentation to be included in submissions to the FDA and other regulatory authorities, including the EU and other global authorities. Additionally, this person will participate in and/or lead interactions with pharmaceutical partners in planning and executing Rx-Dx Co-development regulatory projects. This role will have the unique opportunity to contribute to the development of regulatory submissions in the rapidly growing field of diagnostic next generation sequencing as well as to gain substantial exposure to the scientific and technical aspects of cutting edge technology. The RA Specialist will work closely with both Regulatory Affairs, R&D scientists, biostatisticians and software engineers to produce high quality deliverables for regulatory submission. This role will be critical in ensuring that highly technical documentation is concise and understandable to readers that have a relevant scientific background but may not be well versed in the specifics of our technology.

As a Senior member of the Regulatory team, you will:

  • Contribute to Regulatory Strategy, provide innovative thinking and lead companion diagnostic submissions, pre-submission documents, IDE applications, 510(k) applications, premarket notifications/applications and post-market reporting
  • Lead study risk determination and IDE planning and work closely with BioPharma partners 
  • Opportunity to lead FDA calls and meetings
  • Provide updates to Sr. Management including Executive Leadership team
  • Supervise and approve generation of technical documentation including:
    • Validation Protocols and Reports
    • Software documentation
Requirements
  • Must have:
    • Strong scientific background in Diagnostics OR Medical Devices 
    • Superior technical and scientific writing skills
    • Must be detail oriented with excellent prioritization and organizational skills
    • Ability to deliver results on schedule in a fast-paced, dynamic environment 
    • Ability to distill and simplify complex ideas
  • Highly Desired:
    • Scientific background in oncology 
    • Experience with molecular diagnostics 
    • Experience with regulatory submissions [PMA, IDE, 510(k)] with a manufacturer or in a regulatory consulting role
    • PhD preferred with at least 1 years of experience in the pharmaceutical, biotechnology, medical device, or diagnostic industries, or MS with 2+ years of experience as a technical writer. 
  • Driven. You will be focused on the achievement of major alliance goals.
  • Solutions focused. Willing to bring creative problem-solving skills to challenges along the way. 
  • Scientifically-oriented. You will enjoy learning and being involved in the content of our collaboration activities, and able to converse fluidly with internal and external team members on project goals and activities. 
  • Intuitive. You will have a demonstrated ability to work in the “gray zone” and anticipate challenges before they arise. 
  • Process-oriented, yet flexible. You will appreciate and be able to create and drive process, and at the same time recognize when rules are meant to be bent. 
  • Ability to communicate clearly and concisely with all stakeholders. 
  • Independent. You will be able to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across the collaborations. 

 

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer. The company’s initial clinical product, FoundationOne™, is a fully informative genomic profile to identify a patient’s individual molecular alterations and match them with relevant targeted therapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer.

 

Note to Employment Agencies

Foundation Medicine values our relationships with our Recruitment Partners and will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us.  Foundation Medicine is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Foundation Medicine who is not a member of the Human Resources team.

 

 

 

How to Apply
About Our Organization

WHAT MAKES FOUNDATION MEDICINE SO SPECIAL?

The cancer treatment paradigm is evolving rapidly and we believe there is now widespread recognition that cancer is a disease of the genome, rather than a disease defined solely by its specific anatomical location in the body. Today, physicians increasingly use precision medicines to target cancers based on the specific genomic alterations driving their growth, but most currently available molecular diagnostic tests only reveal a few of the possible alterations. Foundation Medicine provides truly comprehensive molecular information products that can assess the broadest range of relevant genomic alterations from a patient’s tumor and distill this complex molecular information into a concise and actionable format that reveals more treatment options for physicians and their patients.

We've seen the difference that our technology can make in the lives of patients, but there is still enormous potential to help even more people. In our drive to help transform the way in which patients with cancer are treated, we strive to improve every life we touch through our dedication to innovation, our commitment to people, and our passion for performance.

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