Avatar for Vessel

In-home real-time health tracker

VP of Regulatory Affairs

$125k – $160k • 0.0% – 0.1%
Apply now

Full-time

Role and Responsibilities:
-Leading all regulatory affairs, including FDA submissions, HIPAA compliance processes, and labeling decisions
-Reviewing and approving all materials from a regulatory perspective, including packaging, website, ads, and product features.
-Ensure the company is staying compliant with regulations

Mission/Purpose:
Our first core value at Vessel is health over wealth. This means that we put the health of our customers over making a quick buck. In order to do that, We need to maintain great relationships with authorities, stay compliant,and consistently get innovative products approved to sell to customers. The Director of Regulatory Affairs is the person responsible for this. This is a vital role in a health technology company and requires someone who has tremendous knowledge and passion for getting products approved with regulators

Needed Skills:
-Knowledge of FDA regulations and best paths to approvals
-Strong network with officials and FDA members
-Clinical trial skills - knowing the proper protocol that the FDA is looking for
-Attention to detail
-FDA labeling skills - the ability to review content to ensure we are staying compliant
-Teaching ability
-Managing people effectively to follow processes and dealing with non-compliance
-Discipline in the face of urgency (the ability to stand your ground when pressured to not to)
-Organization and planning
-Proactive communication

What technical knowledge do you need to perform in your role?
-FDA submission experience
-HIPAA compliance experience
-Software skills such as Asana, Slack, Google Drive, Doc control software

Qualifications (Must haves):
-3+ years of success in a similar role
-Successfully led 2+ medical device products submission through FDA approval
-Written the protocols for 2+ published clinical trials
-Privacy and data security experience

Qualifications (Nice to Have’s):
-Startup experience (worked at a company with less than 30 employees that scaled rapidly)
-Consumer product experience

Vessel at a glance

In-home real-time health tracker

Vessel focuses on Healthcare, Health Care Information Technology, Personal Health, and Health and Wellness. Their company has offices in San Diego. They have a small team that's between 11-50 employees. To date, Vessel has raised $5.381M of funding; their latest round was closed on February 2020.

You can view their website at http://www.vesselhealth.com or find them on Twitter, Facebook, and LinkedIn.

More jobs at Vessel

View all jobs

Junior Biochemist - Assay Development

Biochemical Engineer - Transfer to Production

Senior iOS Developer

Senior Backend Developer

Head of Digital Product

Art Director