Vice President of Regulatory Affairs

Job Title: Vice President of Regulatory Affairs

Job Location: Manhattan, New York, NY, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Executive

Department: Precision

Location: United States

Compensation: $260,000 - $275,000 / year

Description

Precision is building a direct connection between the human brain and computers to benefit the hundreds of millions of people worldwide suffering from neurological conditions. Established in 2021, Precision is a leader in the development and commercialization of brain–computer interfaces (BCI).

As a Precision employee, you will collaborate with experts across a diverse array of fields– including neurosurgery, mechanical engineering, machine learning, and microfabrication–to push the boundaries of what is possible. You will be joining a well capitalized and fast-moving company. In the three years since Precision's founding, we have built and validated a product and have begun human trials in partnership with some of the country's leading neurosurgery programs. And you will be working toward a deeply meaningful goal: restoring function to people living with devastating neurological conditions, including stroke, spinal cord injury, traumatic brain injury, and neurodegenerative disease such as ALS. Our platform will enable these individuals to regain independence, communicate with loved ones, and return to work.

We are seeking a Vice President of Regulatory Affairs who will be a strategic leader responsible for formulating and executing regulatory strategies that ensure successful market entry and compliance of Class II, III, and 510 (k) medical devices, including premarket approval applications (PMAs) and software as a medical device (SaMD). We seek a regulatory leader who can think beyond traditional frameworks, work closely with product and clinical teams and leverage innovative strategies to address unique challenges. This leader will be a hands-on expert with a deep understanding of the regulatory landscape and demonstrated strong decision-making abilities to support the company's objectives, ensuring both FDA and global regulatory body compliance. They will work closely with cross-functional teams to align regulatory activities with company goals, particularly as we advance the complex medical technologies incorporating both hardware and software components.

This position will be either at our Manhattan (Flatiron neighborhood), Santa Clara, California office or remote. We are unable to consider people not currently based in the United States, and who do not have working rights.

Key Responsibilities

• Pioneering Mindset: Lead regulatory strategy and operations with a pioneering mindset. BCI is an emerging field that demands creativity and vision as we establish new standards and navigate regulatory pathways
• Regulatory Strategy Development: 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.
• Regulatory Submissions and Approval: Draft, manage, and lead regulatory submissions to secure FDA clearances and approvals, including PMAs and IDEs. Develop and maintain expertise in FDA submission processes and requirements, achieving timely approval and clearances for complex, high-risk devices.
• Regulatory Agency Interactions: 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.
• Cross-functional Collaboration: 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.
• International Regulatory Expertise: 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.
• Post-market Surveillance and Compliance: Oversee post-market regulatory activities, including post-market surveillance, reporting, and regulatory audits, to ensure continuous compliance and optimal market access.
• Clinical Trial Applications: Manage regulatory submissions related to clinical trials, including IDEs and other relevant applications, supporting the development and validation of new and existing technologies.
• People Leadership: Provides oversight to assigned teams by recruiting, supervising, guiding, and directing employees, consultants, and regulatory counsel. to be effective team members.
• Risk Management: 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.
  
  
  

Skills, Knowledge and Expertise

• 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.
• Advanced Degree (e.g., MS, MBA, or PhD) in Life Sciences, Regulatory affairs or a closely related field is strongly preferred.
• RAPS and ISO 13485 certification or equivalent experience
• 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.
  
  
  

Diverse workforces create the best culture, company, and products. We at Precision are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Precision does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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