Regulatory Coordinator in California

Who are we and why should you join us?

BetterHelp is on a mission to remove the traditional barriers to therapy and make mental health care more accessible to everyone. Founded in 2013, we are now the world’s largest online therapy service – providing affordable and convenient therapy in 210 countries and over 60 languages across the globe. Our network of over 30,000 licensed therapists has helped millions of people take ownership of their mental health and change their lives forever. And we’re not stopping there – as the unmet need for mental health services continues to grow, BetterHelp is committed to being part of the solution.

As an Legal Operations Specialist, Advertising & Promotions at BetterHelp, you’ll join a diverse team of licensed clinicians, engineers, product pros, creatives, marketers, and business leaders who share a passion for expanding access to therapy. And as a mental health company, we take employee mental health just as seriously as we do...

Who is CorDx？  

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.  

Job Type: Full time  
Job Title: Regulatory Coordinator
Location: Onsite - San Diego

Salary Range: $66,560 - $75,000

Requirements

• Assist in the preparation, compilation, submission, and maintenance of regulatory filings and registrations, including DeNovo and 510(k) submissions for IVD products.
...

CorDx, a thriving biotechnology company, is seeking a Regulatory Coordinator to join our team. In this role, you will assist in the planning and execution of regulatory compliance activities. You will analyze and interpret regulations and guidelines to ensure company compliance and organize necessary documentation. The ideal candidate will be detail-oriented and possess excellent organizational and communication skills.

Requirements

Responsibilities

Assist in the preparation, submission, and maintenance of regulatory filings and registrations, including 510(k) and PMA submissions.

Interpret and communicate industry and regulatory guidance to internal teams.

Coordinate with cross-functional teams to ensure compliance with regulatory requirements.

Manage documentation related to regulatory submissions and approvals.

Prepare post-market surveillance reports, adverse event reports, and...

CorDx, a thriving biotechnology company, is seeking a Regulatory Coordinator to join our team. In this role, you will assist in the planning and execution of regulatory compliance activities. You will analyze and interpret regulations and guidelines to ensure company compliance and organize necessary documentation. The ideal candidate will be detail-oriented and possess excellent organizational and communication skills.

Responsibilities

• Assist in the preparation, submission, and maintenance of regulatory filings and registrations, including 510(k) and PMA submissions.
• Interpret and communicate industry and regulatory guidance to internal teams.
• Coordinate with cross-functional teams to ensure compliance with regulatory requirements.
• Manage documentation related to regulatory submissions and approvals.
• Prepare post-market surveillance reports, adverse event reports, and other regulatory reports.
• Track and maintain...