Company Hidden

Enzyme

Regulatory Affairs Director

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.
Login for details
Open application

Position information

Company: Hidden
Company: Enzyme
Job title: Regulatory Affairs Director
Location: San Francisco, CA
Salary range: $130k - $150k
Enzyme certifications:
Login for details
Open application

Other roles

Company: Hidden
Company: Enzyme
Job title: Intern - Regulatory Affairs / Quality Systems
Location: San Francisco, CA
Salary range: $20k - $60k
Login for details
View details
Company: Hidden
Company: Enzyme
Job title: Senior UX/Product Designer
Location: San Francisco, CA
Salary range: $110k - $130k
Login for details
View details
Ready to level up? Inquire about certification.
info@enzyme.com or

Ready to do more?