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 preparing and submitting 510(k) and PMA submissions to FDA and 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.
Think TurboTax, but for FDA.
We’re building a software platform to handle the compliance aspects of running a drug or medical device company. Compliance is an ongoing activity for companies in this space, and annual costs per company range anywhere from $100K to $100M. Being deemed not compliant can be devastating, preventing a company from selling any new product for months and sometimes years.
In lieu of hiring costly consultants or employees to address this problem, customers provide our platform access to their data, and the platform outputs documentation in the manner that FDA and other regulatory agencies are looking for.
By using our software platform, customers will cut their annual regulatory costs by 50% (on average) and reduce the risk that their products will not get approved for sale.