Regulatory Affairs Director

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About Lark

Lark is the world's largest A.I. healthcare provider, servicing nearly 2 million patients living with or at risk of a chronic disease. Lark is a companion app on the user’s phone providing real-time coaching, guidance, and health insights to users. We are on a mission to disrupt the healthcare industry and make the world a healthier, happier place. Come join our team!

 

The Role
Lark is seeking a talented Regulatory Affairs Director to join our growing team!  This position is responsible for delivering on regulatory requirements for Lark Health. Responsible to lead, manage and support development activities and submissions, manage regulatory filings, and review commercial materials. You will need to work collaboratively with other team members and subject matter experts in Marketing, Sales, Strategy, Product, and Healthcare Operations.

 

What You’ll Do

  • Prepare, review and complete regulatory submissions for Federal and Industry program certifications and annual reports 
  • Collaborate with leadership, business unit stakeholders, clinical and regulatory staff to ensure that all regulatory documents are prepared, reviewed, and filed in a timely fashion
  • Prepare and submit all required documents in preparation of certification, and all pertinent follow-up documentation
  • Provide updates and communicate with sponsor, project manager, study start up and clinical team to anticipate, identify and resolve issues
  • Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations
  • Provide regulatory guidance and quality assurance assessments for assigned research projects - domestic and international
  • Develop training modules and presentations to ensure compliance with applicable regulatory regulations, CFR, FDA/ICH guidelines
  • Create SOPs, work instructions, and procedures for regulatory operations
  • Serve as a member of the team, or committees related to regulatory affairs, and quality assurance
  • Mentor and train others on tasks or systems

What You’ll Need

  • Good negotiating skills and the ability to identify and resolve issues, using a flexible adaptable approach 
  • Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision 
  • Must be able to independently coordinate with interdisciplinary team members, manage timelines for and compile documents for submissions, with minimal oversight
  • Ability to propose revisions to SOPs or suggest process improvements for consideration
  • Familiar with and able to identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory bodies
  • Excellent analytical and communication skills 
  • Demonstrated skills in chairing small meetings
  • Bachelor’s degree in a relevant scientific field, an advanced degree is preferred or equivalent work experience
  • 10+ years’ experience with North American regulatory submissions experience to include briefing packages, response to FDA questions, and certification submissions
  • 5+ years of work experience in areas relevant to regulatory affairs, quality assurance, and clinical research
  • Experience with FDA Software as a Medical Device regulations and private healthcare accreditation agencies such as NCQA, URAC, and the Joint Commission
  • Strong software and computer skills, including MS Office applications
  • Ability to travel a minimum of 20% is required domestically

Working at Lark 

Lark offers the option to work remotely in the United States.  For Colorado Applicants only: minimum annual salary is $151,000 (minimum salary varies for other geographies). You may also be offered a bonus, stock options and/or benefits.  The company is headquartered in Mountain View, CA.

 

Lark is an Equal Opportunity and Affirmative Action Employer. We believe that diverse teams foster innovation and add to our mission-driven culture. We strongly encourage people from underrepresented groups to apply.


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More Information on Lark Health
Lark Health operates in the Healthtech industry. The company is located in Mountain View, CA. Lark Health was founded in 2011. It has 120 total employees. It offers perks and benefits such as Friends outside of work, Eat lunch together, Daily sync, Open door policy, OKR operational model and Open office floor plan. To see all 3 open jobs at Lark Health, click here.
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