Regulatory Affairs Director


San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Post Date: 12/29/2020
  • Website:
  • Company Address: , San Francisco, CA

About Enzyme

Enzyme’s mission is to automate and simplify life science regulatory approval and compliance. We reduce your cost of compliance and help bring your cutting-edge technology to market faster.

Job Description

Enzyme is hiring a Regulatory Affairs Director to lead and manage the development of its regulatory software and services for medical device and diagnostic companies.

The Regulatory Affairs Director will:

Act as Product Owner for Enzyme's regulatory automation software: 
- Work with Enzyme's engineering leadership to develop product requirements 
- Review software-in-development and provide feedback for the engineering team 
- Develop a roadmap for future product improvements and releases

Own the RA services function and team: 
- Manage future RA personnel 
- Aid in retaining and motivating talent 
- Work with the founders to recruit new team members 
- Put in place the right processes for personnel development and training 
- Provide final review for all submissions and other communication to regulators that Enzyme develops on behalf of its customers

Successful candidates will have 8+ years experience, and candidates MUST have experience preparing and submitting at least 2 of any of the following: 510(k), IDE, and PMA submissions to FDA or technical files to notified bodies.

Preference will be given to candidates who have worked with multiple emerging companies, and/or candidates who have worked as regulatory affairs consultants in the past. Preference will be given to candidates who have worked across multiple indications/FDA divisions (as opposed to one subspecialty), and candidates who have worked with hardware, electromechanical, software, IVDs, and is familiar with 21 CFR Part 11.

Position will involve 20-30% travel and will be based in San Francisco, CA. Salary and equity grant commensurate with experience.


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