Head Of Regulatory Affairs - Digital Health
- Employer
- Catalyst Life Sciences
- Location
- Walton, NY
- Closing date
- Sep 23, 2021
View more
- Sector
- Pharmaceutical, Regulatory Affairs
- Organization Type
- Corporate
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A 100% remote opportunity to join the market leader for AI medical technology to improve the overall effectiveness of the oral healthcare industry from a provider and patient outlook. Spring-boarding off their recent success, FDA authorizations within digital health, and rounds of funding, as the Regulatory Affairs Director you'll have the chance to drive the regulatory submissions and strategy for upcoming indications and product lines!
Main Responsibilities:
Experience Required:
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
Main Responsibilities:
- Developing and implementing the regulatory strategies and roadmaps, utilizing experts, consultants, and key contacts in the SaMD space for rapid approvals.
- Planning, coordinating, preparing, and completing document packages for regulatory submissions - primarily 510(k)s with upcoming plans for global submissions.
- Leading meetings and corresponding with the FDA and other international regulatory bodies for approvals and ongoing reporting
- Hiring and developing a world class team to deliver regulatory compliance
Experience Required:
- At least 8 years of regulatory approval processes related to medical devices, and a proven track record of being a part of a team to gain a successful approval for a software as a medical device (SaMD)
- Motivation to work part of a growing organization and being able to define the regulatory processes as the business increases in headcount and regulatory responsibilities.
- Direct interactions and experience managing medical device approval processes with the FDA, EU Notified Bodies, and other global regulators
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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