Senior Regulatory Manager

COMPANY

EverlyWell provides direct-to-consumer home health tests with easy-to read and actionable results. We are at the forefront of personalized health, transforming the $25B lab testing industry. We’re here to empower people to take control of their health by making lab testing easy to access, understand, and afford.

ROLE SUMMARY

We are hiring an experienced Senior Regulatory Manager who will be responsible for development and implementation of regulatory strategies for all EverlyWell products. Through cross-functional collaboration, you will lead and provide tactical guidance to program teams, prepare regulatory submissions and liaise with FDA and other health authorities as required. Additionally, you will direct and conduct the regulatory affairs aspects of review and approval of medical and commercial material supporting external scientific communications for all products in the EverlyWell portfolio. This is a leadership position within Compliance and will represent the department on product teams and requires a comprehensive understanding of strategic labeling. You will have significant interactions with Marketing, Medical, Technology and Product teams, leading to product launch. We are in high growth, startup mode and need someone who is willing to get their hands dirty. If you are passionate about all things Regulatory and looking for an opportunity to design and build a Regulatory function for an amazing company, this role is the one for you.

What You’ll Be Responsible For:

● Participate in the product development team for early development product to provide labeling leadership in developing target labeling concept to guide the design and analysis plan for clinical studies.
● Manage regulatory submissions to FDA; draft responses to Agency queries and revised labeling and other requirements for submissions; track FDA requests and responses.
● Prepare the submission documents including coordination of all exhibit materials. Maintain and tracks documents in the document repository as appropriate.
● Serve as an internal expert on regulations (FDA and state level regulations), guidance, and enforcement trends governing the promotion of medical devices, and provide guidance to others.
● Ensure compliance with applicable laws, regulations and FDA guidelines.
● Coordinate with the laboratory Quality Assurance Supervisor to ensure regulatory requirements are being met.

Your Education & Experience:

● Bachelor’s degree required; advanced degree preferred.
● Experience with medical device regulatory submissions (EUA, 510(k) or PMA).
● You have at least seven to 10 years of experience in medical device and/or biopharmaceutical and/or agency/medical education company experience.
● Comprehensive knowledge of regulations and guidance governing medical device development and maintenance.
● Proven ability to lead and influence others and to collaborate effectively with peers, teams, and with senior leadership.
● Clear and effective verbal and written communication skills, and persuasive project management and presentation skills.
● Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships.
● Experience working on cross-functional teams and within a review committee.
● Ability to implement and manage multiple projects simultaneously, with high attention to detail.
● Prior experience in a fast-paced startup environment a plus
HIPAA Disclaimer: This role will be in an environment that has access to protected health information (PHI) and all security standards to protect PHI must be followed.