Linus Health

Director of Regulatory Affairs & Quality Assurance

Boston/San Diego/Toronto
Published on: September 22, 2021

Description

We are a human-centered digital health company that seeks to radically improve brain health outcomes by leveraging cutting-edge technology and machine learning to unlock precision brain health for as many people as possible. While we are steadfastly focused on individuals’ brain health, we believe that meaningful outcomes can only be achieved within an ecosystem of care that actively includes and engages physicians, professionals and caregivers. We are a team of 50+(and rapidly growing!), embarking on an exciting period of accelerated growth.  We invite collaborative, self-driven and impact-oriented professionals to join our dynamic and fast-growing team.

Does this sound like an innovative & disruptive start-up where you could see yourself?  Do the following values resonate with you?

Be Real

Be Wise

Be Noble 

Be A Team

Be Masters of Our Craft

Think Big and Act Bold

If so, please continue reading..

Please note that we are building our hubs across Toronto, Boston & San Diego so those are the preferred locations.  However we are open to nationwide remote for an exceptional candidate.

What You’ll Do:

  • The QA & RA Director will act as the management representative for Linus Health; the duty of this task is to act as the point of contact for all regulatory communication in the company, including incident reports, audits, registrations, etc.  
  • Establish, manage and maintain compliance with FDA QSR, including establishment registration, new product submissions, CAPA System.  
  • Establish, manage and maintain compliance with MDD 93/42/EEC directive, including CE Mark applications via Technical Files  
  • Oversee and manage initiatives for SOC2 and NIST 800-53 compliance and related security controls
  • Responsible for the quality and regulatory control for products in which Linus Health is the Legal Manufacturer  
  • Manage and maintain compliance to ISO13485 requirements  
  • Responsible for responding and reporting incidents to all approved markets 
  • Responsible for the Customer Complaint System  
  • Responsible for managing product failures and appropriate corrective actions  
  • Responsible for defining the Company’s quality goals each year 
  • Manage the Quality Assurance and Regulatory department 
  • Develop yearly target budget and capital plan 
  • Manage QA & RA expenditure against budget

About You:

Must Haves:

  • A Bachelor of Science Degree in Engineering, Quality or a related field
  • 10+ years’ experience in Quality Assurance and Regulatory affairs within the medical devices field of use.  
  • Extensive knowledge of FDA and HIPPA requirements for medical devices and supporting systems.
  • FDA Regulatory 510(k) submission experience

What We Offer:

  • As a health and wellness company, an opportunity to have a lasting impact on the way people and communities engage with brain and mental health, and even to affect the prognoses of people’s mental and brain health trajectory
  • A mission driven environment where all 50+ employees strive to exemplify our core values every day
  • Competitive compensation packages that include an annual discretionary target bonus incentive as well as valuable equity
  • Unlimited PTO -- We know this can work both ways, however our leadership team does an excellent job at encouraging people to take PTO
  • A sincere and deep appreciation for the importance of mental health: We have recently implemented a “monthly flex day” where employees are encouraged to take time away from work to rest, recharge & reset.
  • A peer-to-peer recognition program: Celebrating our employees’ hard work and success is in our DNA!
  • Employee Referral Incentive program
  • A robust healthcare package that includes medical, dental & vision benefits as well as a 401(k) program where Linus will match up to 6% of employee contributions

Linus Health is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, religion, color, national origin, sexual orientation, gender, gender identity or expression, age, genetic information, disability or any characteristic protected by law. We believe that diversity is critical to the growth of our company and understand the importance of fostering an environment where everyone has a voice. We are also committed to providing reasonable accommodations for candidates with disabilities during the recruiting process. If you are in need of assistance due to a disability, please contact us.

Apply for this job