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Head of Regulatory Affairs

Organization
SOPHiA GENETICS
Job Location
201 Washington Street
Boston, MA 02108
United States
Job Description

Reporting

Directly to Vice President Legal

Key Responsibilities and deliverables

  • Develop regulatory strategy for complex projects.
  • Develop and prepare submissions to regulatory agencies required to allow SOPHiA GENETICS products and services to be marketed in the America Region (FDA, Health Canada).
  • Review and edit technical documents to be included in submissions and pull in subject matter experts as needed.
  • Lead interactions with regulatory agencies and other external partners.
  • Monitor regulatory agencies for changes in policies and procedures and implement changes as required to maintain registrations, maintain knowledge about applicable standards, directives and guidance’s necessary to facilitate notifications and submissions to regulatory agencies 
  • Implement and support regulatory compliance activities .
  • Provide regulatory guidance and expertise, and train staff on regulatory procedures.
  • Act as a liaison with other departments, e.g., Quality, R&D, IT, Legal 

Knowledge, Skills and Experience Required 

Education

  • Master degree in life sciences e.g. biology, pharmacy, biotechnology.
  • Proven track record in Regulatory Affairs 
  • Fluency in spoken and written English, other languages an asset 
  • Knowledge, understanding and experience in life sciences, MedTech exposure a plus
  • Knowledge of regulatory standards (FDA 21 CFR part 820, MDSAP) and regulatory agencies submissions
  • 5 years of relevant experience

Required skills

  • Ability to leverage relationships across other departments and with prioritization. 
  • Excellent computer skills which includes working on electronic databases and good knowledge of MS office applications.
  • Good knowledge and proven application of administration processes and systems.
  • Results oriented, good attention to detail and problem-solving skills.
  • Able to work independently as well as participating in a team of professionals 
  • Effective administration skills, good planning and organizing skills.
  • Must use initiative, be proactive and have good follow-up skills.

Location : Boston 

Starting: ASAP

 

About Our Organization

Ranked among the "50 Smartest Companies" in the world according to the MIT Technology Review, SOPHiA GENETICS is a fast-paced growing health-tech company. Combining deep expertise in life sciences, medical disciplines and mathematical modeling, we bring to market data analytics solutions to support healthcare professionals in better diagnosing and treating patients. Today SOPHiA’s technologies are being adopted and trusted by over 850 leading hospitals worldwide, all connected to each other and motivated to provide equal benefits to all patients.

In our mission to democratize Data-Driven Medicine, we are looking for passionate and dedicated individuals to join our growing dynamic team. Does this sound like you? If so, we want to hear from you…

 

Check out our website : sophiagenetics.com | Follow us on Twitter @SOPHiAGENETICS and Linkedin

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