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Automating FDA compliance and approval

Regulatory Affairs Director

$130k – $150k • 1.0% – 3.0%
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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.

Meet your team

People you would work with in this role
VP QA/RA and Co-founder of Enzyme.com providing FDA compliance as a service - reducing regulatory burden and risk while helping to minimize time to market

Miscellaneous

Check out the Benefits & Perks sections of our handbook: https://github.com/EnzymeCorp/handbook#perks

Enzyme at a glance

Automating FDA compliance and approval

Enzyme focuses on Biotechnology, Enterprise Software, Medical Devices, Health Care Information Technology, and Artificial Intelligence. Their company has offices in San Francisco and Remote. They have a small team that's between 11-50 employees.

You can view their website at https://www.enzyme.com or find them on Twitter and LinkedIn.

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