83 applicants

Company

Precision Neuroscience · 1 day ago

Vice President of Regulatory Affairs

Manhattan, NY

Full-time

Remote

Director/Executive

$260K/yr - $275K/yr

10+ years exp

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Responsibilities

Lead regulatory strategy and operations with a pioneering mindset.

Formulate and implement comprehensive regulatory strategies for new and existing Class II and Class III medical devices, covering FDA submissions(510(k), De novo, PMA) and other global regulatory pathways, ensuring alignment with both company objectives and compliance standards.

Draft, manage, and lead regulatory submissions to secure FDA clearances and approvals, including PMAs and IDEs.

Act as a primary regulatory interface with FDA, including our regulate TAP meetings and other global regulatory bodies, leading meetings, communications, and negotiations to facilitate a clear and productive pathway to regulatory approvals.

Partner closely with R&D, Clinical, Quality, and other teams to ensure that product development and post-market activities comply with all regulatory requirements, maintaining a proactive approach to regulatory compliance.

Develop and oversee strategies for obtaining regulatory approvals from notified bodies outside the US, especially for international market expansion, ensuring compliance with local regulatory requirements and Standards.

Oversee post-market regulatory activities, including post-market surveillance, reporting, and regulatory audits, to ensure continuous compliance and optimal market access.

Manage regulatory submissions related to clinical trials, including IDEs and other relevant applications, supporting the development and validation of new and existing technologies.

Provides oversight to assigned teams by recruiting, supervising, guiding, and directing employees, consultants, and regulatory counsel. to be effective team members.

Anticipates regulatory and related obstacles and emerging issues throughout the product life cycle in conjunction with the quality team. Provides the company with updates on the current and changing regulatory environment and its impact on Precision.

Qualification

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FDA regulatory submissionsClass III medical devices510(k) applicationsPMA applicationsIDE submissionsPost-market surveillanceRegulatory auditsLife Sciences degreeRAPS certificationISO 13485 certificationProject managementCollaboration skills

Required

Proven track record of successful FDA regulatory submissions and clearances, particularly with Class III medical devices and complex systems integrating hardware and software.

Extensive experience interfacing directly with the FDA and other regulatory agencies.

Demonstrated expertise in drafting and executing regulatory submissions for FDA approval including 510(k), Breakthrough, DeNovo, and PMA applications

Experience in dynamic company environments including small to medium-sized organizations.

Extensive experience with IDE submissions, post-market surveillance, and regulatory audits.

10 years of regulatory experience in the medical device industry, with at least 5 years in a senior or executive regulatory role.

Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs or a related field is required.

Strong-decision making and project management abilities, with the capability to manage multiple initiatives simultaneously.

Exceptional verbal and written communication skills, with the ability to communicate complex regulatory concepts clearly to FDA, internal teams, and leadership.

High attention to detail, analytical skills, and a proactive, solution-oriented approach to regulatory challenges.

Excellent communication and collaboration skills, with experience working in cross-functional teams.

Ability to thrive in a fast-paced, innovative environment.