Regulatory Affairs Director at Enzyme
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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