ABOUT HAPPIFY HEALTH:

 

Happify Health is a world leader in the development and delivery of digital mental health solutions, including digital therapeutics. Our platform has been made accessible to over 10 million people and is used by millions.

 

We are scientists, researchers, health care clinicians, and digital gaming experts passionate about bringing our unique expertise and areas of knowledge together to think differently and to create new highly effective approaches to mental health, making them accessible through technology 

 

ABOUT THE ROLE:

Happify Health is seeking an experienced and dynamic candidate to join our growing team as the Regulatory Affairs  Manager (RA Manager).  This candidate will report directly to the VP of Quality and Regulatory Affairs.  The RA Manager will be responsible for authoring submission packages for the US markets, Europe, Asia and RTW as well as supporting  the development and implementation of regulatory strategy.   This position will routinely interact with the clinical team, the operations team, the marketing team as well as other Happify team members.


***This position would work out of our Boston-area office.*** Some remote work days possible. Travel to conferences and other speaking opportunities is possible. Travel to regulator meetings may be required.

 

 

RESPONSIBILITIES:

The RA Manager will be responsible for many different activities to support department and corporate goals. Primary responsibilities for this position are to:

  • Develop and implement regulatory strategy
  • Develop, implement and oversee execution of the regulatory affairs roadmap
  • Keep abreast of current regulations that affect our products
  • Author/review submissions as required including but not limited to 510Kte and technical files
  • Prepare and maintain regulatory files
  • Participate in FDA meeting as required
  • Support business team members with regulatory needs
  • Post approval regulatory compliance
  • Review and approve labeling and claims
  • Review and provide summary of regulations that affect our products
  • Other responsibilities as assigned

 

 

QUALIFICATIONS:

The ideal candidate should have:

 

  • A minimum of a BA/BS in a scientific discipline with at least 5 years of Medical Device Quality Systems Experience (ideally in digital therapies or software as a medical device)
  • Experience completing 510K submissions and Technical Files
  • Strong knowledge of FDA regulations, EU regulations, Health Canada regulations and RTW
  • RAPS certification preferred
  • Excellent communication skills both verbal and written
  • Detail oriented, well organized and ability to work across the organization
  • The ideal candidate will demonstrate effective problem-solving skills and be proficient in MS Office and Google applications, as well as a general comfort with new technology

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