Head of Clinical and Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Head of Clinical and Regulatory Affairs based in the United States.

This role provides strategic and operational leadership across Clinical Affairs, Clinical Operations, Clinical Science, and Regulatory Affairs for an innovative medical device platform.
You will own the clinical lifecycle end-to-end, with an immediate focus on executing complex multi-site trials for implantable neuromodulation technology.
The position combines clinical execution, regulatory strategy, evidence generation, team leadership, and cross-functional product development.
You will work closely with executive leadership, R&D, Quality, Operations, Marketing, CROs, clinical sites, and regulatory authorities to advance programs efficiently.
A major focus will be building a scalable clinical and regulatory organization capable of operating with high autonomy as the company grows.
This is a highly visible opportunity to shape clinical strategy, engage leading experts, and contribute to the development of technologies designed to address significant unmet needs in mental health.

\n

Accountabilities:

As Head of Clinical and Regulatory Affairs, you will lead the clinical and regulatory functions while ensuring studies are executed efficiently, compliantly, and in alignment with product development and approval objectives.

• Oversee the full clinical lifecycle, with an immediate focus on Clinical Operations, including site activation, patient enrollment, contracting, and Field Clinical Engineer execution.
• Lead multi-national, industry-sponsored clinical trials in collaboration with CROs, specialized vendors, consultants, and clinical sites.
• Oversee study design, site strategy, patient recruitment, data quality, and clinical execution to support regulatory and product performance objectives.
• Guide endpoint selection, statistical analysis plans, data interpretation, and broader evidence-generation strategies.
• Develop evidence strategies across sponsored, partnered, and grant-funded research to inform future studies, reduce technical risk, and strengthen confidence among stakeholders and investors.
• Manage clinical trial budgets, timelines, resources, operational risks, and mitigation plans to support on-time and in-budget delivery.
• Lead regulatory strategy and execution, including IDE submissions and other regulatory filings for current and future products.
• Represent the organization in interactions with the FDA and other regulatory authorities, including pre-submission meetings.
• Oversee post-market surveillance, adverse event reporting, post-approval study commitments, and ongoing regulatory compliance obligations.
• Hire, onboard, develop, and manage clinical and regulatory personnel while building scalable teams and processes.
• Partner with R&D to ensure regulatory and clinical requirements are incorporated early into product design and development.
• Collaborate with cross-functional teams to ensure clinical strategies support product approval, development, reimbursement, and market access objectives.
• Identify, engage, and maintain relationships with global and regional Key Opinion Leaders to guide clinical strategy and strengthen program credibility.
• Represent the Clinical and Regulatory function internally and serve as a strategic connector between executive leadership, technical, marketing, and operations teams.
• Represent the organization externally at clinical sites, industry conferences, scientific meetings, and other professional forums.
• Serve as the regulatory subject matter expert during audits and inspections in partnership with Quality leadership.
• Travel to Houston for headquarters meetings, as well as to conferences, clinical sites, and other professional engagements as required.

Requirements:

The ideal candidate is an experienced clinical and regulatory leader with deep expertise in active implantable medical devices, neuromodulation, and multi-site clinical trial execution, combined with the adaptability required to thrive in an early-stage environment.

• 12+ years of experience spanning clinical and regulatory functions within a medical device company focused on active implantable devices, including at least 4 years of experience in neuromodulation or implantable BCI devices.
• 6+ years of experience partnering with cross-functional teams on clinical study design supporting product development and regulatory approval strategies.
• 6+ years of experience managing clinical trial budgets, resources, timelines, and risks, with a demonstrated record of delivering studies on time and within budget.
• 5+ years of direct management experience leading clinical and/or regulatory teams.
• Demonstrated experience leading a multi-function clinical department.
• Proven experience developing and executing regulatory strategies and submissions for implantable neuromodulation devices, including direct interaction with the FDA through pre-submission meetings, IDE submissions, and related activities.
• Direct, hands-on ownership of multi-site clinical trials from site activation through study close-out.
• Experience working in a startup or small-company environment where strategic leadership is combined with hands-on execution of tactical priorities.
• Proven ability to represent an organization at clinical sites, scientific meetings, conferences, and other professional forums.
• Experience managing CROs, specialized vendors, and consultants supporting industry-sponsored clinical trials.
• Working knowledge of GCP, ISO 14155, and applicable medical device regulatory requirements.
• Demonstrated ability to build and maintain strong relationships with KOLs.
• Strong strategic communication and cross-functional collaboration skills.
• Experience overseeing clinical science functions, including evidence strategy, endpoint selection, statistical analysis plans, and data interpretation, is a plus.
• An established KOL network across neurology, neurosurgery, psychiatry, or related fields is a plus.
• Must be authorized to work in the United States; visa sponsorship is not currently available.
• Willingness and ability to travel to Houston approximately 4–5 times per year, as well as attend scientific conferences and clinical meetings as needed.

Benefits:

• Remote position, with Houston, Texas preferred.
• Medical, dental, and vision insurance for employees and dependents.
• Participation in a 401(k) plan.
• Unlimited paid time off.
• Opportunity to build and lead clinical and regulatory functions within an innovative medical device environment.
• High level of autonomy and direct strategic interaction with leadership.
• Opportunity to work with a multidisciplinary team focused on advancing neuromodulation technology.
• Exposure to clinical development, regulatory strategy, product development, scientific research, and KOL engagement.
• The role’s level and title may be determined based on the candidate’s experience.

\n

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

 Why Apply Through Jobgether? 

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

#LI-CL1