Regulatory Open Forum

BioIntelliSense is ushering in a new era of continuous health monitoring and clinical intelligence for Remote Patient Monitoring (RPM) and Screening (COVID-19/Infection). Our medical-grade Data-as-a-Service (DaaS) platform seamlessly captures multi-parameter vital signs, physiological biometrics and symptomatic events through an effortless patient experience. The FDA-cleared BioSticker™ and BioButton™ devices make remote monitoring and early detection simple. Through the platform's advanced analytics, clinicians, patients, and employers will now have access to high-resolution patient trending and reporting to enable medical grade care at home, and medical grade screening in the office, school, or residence. For more information on how BioIntelliSense is redefining remote patient monitoring through medical-grade and cost-effective data services, please visit our website at BioIntelliSense.com. 

Our headquarters is located at the foothills of the Rocky Mountains near historic Golden, Colorado with an additional office located in Northern California (Redwood City).  

About the Role

Our Quality & Regulatory team is growing, and we are looking for a Regulatory Affairs Specialist to assist assigned regulatory affairs activities relating to US and OUS pre-market and post-market activities within the medical device industry. This position reports to the Head of Regulatory and will be responsible for:

• Drafting and reviewing regulatory submissions, including IDE, Q-sub, 510(k), De Novo Requests and PMA submissions, as applicable
• Preparation of regulatory submissions in geographic regions outside the United States (OUS)
• Assisting post-market regulatory activities, domestic and overseas 
• Managing interactions with regulatory authorities, notified bodies and certification bodies
• Conducting training on topics as needed

What We Are Looking For

• Bachelor's Degree in Life Sciences, Engineering, or Computer Science required
• MS or PhD in a similar discipline preferred
• Minimum of 4 years of experience in regulatory affairs within medical device companies 
• Understanding of, and ability to analyze and apply regulations and standards related to the FDA
• Familiarity with other Health Agency regulations and standards (European Union, Health Canada, ANVISA, C-FDA/S-FDA, etc.) preferred
• Must have experience authoring and submitting 510Ks
• Strong written and oral communication skills
• Strong project management skill – being able to navigate through multiple projects within the same time frame 
• Proficient in Excel, Word, and PowerPoint skills and ability to independently produce documents or aptitude to develop this level of skill within a defined period
• Self-directed and independent with the ability to perform with minimal direct supervision

Desired Qualifications

• Prior experience in software, engineering, or manufacturing is preferred
• Familiarity with privacy and security regulations and implementations of the regulations 

Job Type: Full-time – Exempt

Salary Expectations: $125-150K total compensation (based on experience and location) 

Work Location: Golden, CO or Redwood City, CA

Estimated Travel: Ability to travel up to 20% of time

You're excited about this opportunity because you will…

• Join a fast-growing company and grow right along with us.
• Work on challenging and interesting tech problems which reshapes the future of healthcare.
• Get the chance to work on cutting-edge technologies and use world-class tooling to get the job done.
• Make a large impact across the company through business deliverables and continuous innovation.
• Opportunity to build solutions and organizations from 0 to 1.

Why You'll Love Working at BioIntelliSense

• We are leaders - Leadership is not limited to our management team. It's something everyone at BioIntelliSense embraces and embodies.
• We are doers - We believe the only way to predict the future is to build it. Creating solutions that will lead BioIntelliSense and healthcare industry is what we do - on every project, every day.
• We are learning - We're not afraid to dig in and uncover the truth, even if it's scary or inconvenient. Everyone here is continually learning on the job, no matter if we've been in a role for one year or one minute.
• We have great benefits - Medical/Dental/Vision/Life (at little to no cost to the employee), Disability (STD & LTD), 401(k) matching, 10 Paid holidays per year, generous vacation paid time off

**BioIntelliSense is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran, disability status or any other status protected under federal, state or local law.