Linus Health

Quality & Regulatory Compliance Specialist

Remote, United States
Published on: June 24, 2022

Description

Linus Health is a Boston-based digital health company focused on transforming brain health for people across the world. By advancing how we detect, diagnose, and address cognitive and brain disorders – leveraging cutting-edge neuroscience, clinical expertise, and artificial intelligence – our goal is to enable a future where people can live longer, happier, and healthier lives with better brain health.

We are a team of 90+(and 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…

Although we are focused on building out our hubs across Boston, Toronto & San Diego, remote applicants(US & Canada) will be considered. Due to the nature of the role & specific job requirements, unfortunately, we are not able to consider remote applicants who are currently based in Colorado at the moment. Unfortunately, we are not able to provide sponsorship for any of our roles at the moment. 

What You’ll do:

  • The Quality & Regulatory Compliance Specialist will report to the management representative for Linus Health with a goal towards becoming the management representative within 1-2 years; the duty of this task is to assist and then 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 including implementation of an eQMS..  
  • Establish, manage and maintain compliance with MDD 93/42/EEC directive, including CE Mark applications via Technical Files  
  • Oversee and support 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 and NSAI requirements  
  • Responsible for responding and reporting incidents to all approved markets 
  • Responsible for the Customer Complaint System in conjunction with customer success
  • Responsible for managing product failures and appropriate corrective actions  
  • Responsible for working with executive management to define the Company’s quality goals each year 
  • Assist in managing the Quality Assurance and Regulatory department 
  • Work with management to develop yearly target budget and capital plan 
  • Help manage QA & RA expenditure against budget

About You:

  • BS degree in a relevant field
  • 4-7 years’ experience in Quality Assurance and Regulatory affairs within the software as a medical device field of use.  
  • Extensive knowledge of FDA and HIPPA requirements for medical devices and supporting systems.
  • At least 1-2 years management 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 prognosis of people’s mental and brain health trajectory (pretty powerful stuff if you ask me!)
  • A mission-driven environment where all 90 (and counting) 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.

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