Head of Clinical and Regulatory Affairs

New

JobgetherMedical Devices

Based in the United StatesFull-TimeSenior

Salary not disclosed

Apply NowOpens the employer's application page

Job Details

12+ years of experience in clinical and regulatory functions within a medical device company.
4+ years of experience in neuromodulation or implantable BCI devices.
6+ years of experience partnering on clinical study design supporting regulatory approval.
6+ years of experience managing clinical trial budgets, resources, timelines, and risks.
5+ years of direct management experience leading clinical and/or regulatory teams.
Demonstrated experience leading a multi-function clinical department.
Proven experience executing regulatory strategies and FDA submissions (IDE, pre-submission meetings).
Hands-on ownership of multi-site clinical trials from activation through close-out.
Experience in startup or small-company environments.
Working knowledge of GCP, ISO 14155, and medical device regulatory requirements.
Ability to travel to Houston approximately 4–5 times per year, plus conferences and clinical meetings.

Oversee the full clinical lifecycle, including site activation, patient enrollment, contracting, and Field Clinical Engineer execution.
Lead multi-national, industry-sponsored clinical trials in collaboration with CROs and specialized vendors.
Develop evidence strategies and guide endpoint selection, statistical analysis, and data interpretation.
Manage regulatory strategy and filings, including IDE submissions and direct interaction with the FDA.
Build, manage, and mentor scalable clinical and regulatory teams and processes.
Partner with R&D and cross-functional teams to integrate regulatory requirements into early product development.
Represent the organization to regulatory authorities, clinical sites, and Key Opinion Leaders.

View Full Description & ApplyYou'll be redirected to the employer's site