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Job Title: Regulatory & Clinical Operations Manager

We are seeking an experienced Regulatory & Clinical Operations Manager to lead both regulatory submissions and the end-to-end execution of multi-site international clinical trials, including pivotal studies required for FDA approval of Class III implantable medical devices. This role encompasses oversight of clinical trial operations and regulatory strategy—ensuring the successful design, implementation, and management of pivotal studies, while coordinating with CROs, regulatory agencies, and clinical sites to support timely and compliant submissions such as Investigational Device Exemption (IDE) and Premarket Approval (PMA) applications.

Key Responsibilities:

Regulatory Strategy & Execution:

• Lead development and preparation of key regulatory submissions, including IDE applications, PMA support documentation, amendments, annual reports, and clinical study modules (e.g., FDA Module 5).
• Serve as the regulatory liaison with the FDA and other regulatory authorities for clinical trial communications, including pre-submissions, safety reporting, and responses to regulatory queries.
• Interpret and apply FDA regulations (21 CFR Part 812, Part 50, Part 56), ICH-GCP (E6), and ISO standards (e.g., ISO 14155) relevant to Class III devices.
• Ensure all trial activities are in compliance with global regulatory requirements (FDA, Health Canada, EU MDR, etc.) for investigational Class III implants.
• Contribute to regulatory strategy development to support overall clinical and commercial objectives, aligning trial designs with eventual IDE & PMA submission needs.

FDA Pivotal Clinical Trial Management:

• Lead planning, execution, and oversight of early feasibility studies and FDA pivotal clinical trials, ensuring data integrity, patient safety, and regulatory compliance.
• Collaborate with cross-functional teams to design trials with appropriate endpoints, statistical power, and clinical significance aligned with regulatory approval pathways.
• Oversee trial risk management, safety reporting (SAEs, UADEs), and compliance with FDA IDE regulations.
• Develop and manage the clinical trial strategy, including study design, patient recruitment, and endpoints, in alignment with FDA requirements for successful submission and approval.

Clinical Trial Design & Planning:

• Lead the development of clinical trial protocols, study charters, and operational plans for multi-site international trials, ensuring they are aligned with both FDA and local regulatory requirements.
• Collaborate with key stakeholders (e.g., medical, regulatory, quality assurance) to ensure clinical trial design is scientifically robust and compliant with regulatory expectations.
• Develop and manage institutional applications for trial approvals, facilitating timely and efficient submission to regulatory bodies, ethics committees, and Institutional Review Boards (IRBs).

Data Monitoring and Safety Board (DMSB) Setup & Oversight:

• Establish and manage independent DMSBs, including charter development, meeting facilitation, and communication of safety findings to stakeholders and regulators.
• Ensure interim safety analyses and risk evaluations are conducted per protocol and regulatory timelines.

Contract Research Organization (CRO) Oversight:

• Select, qualify, and manage CRO partners for monitoring, data management, and logistics.
• Oversee compliance of CROs with study protocols, FDA regulations, GCP, and sponsor expectations.

Site Management & Monitoring:

• Oversee the selection, initiation, and monitoring of clinical trial sites for multi-site international trials, ensuring sites are compliant with FDA requirements and GCP.
• Develop and execute comprehensive site monitoring plans, ensuring that clinical sites are trained on protocol adherence, FDA regulatory compliance, and patient safety.
• Perform site visits (or manage CRO site visits) to monitor progress, data quality, and compliance, and resolve any issues to maintain timelines and data integrity.

Clinical Trial Logistics & Materials Oversight:

• Ensure investigational product (IP) and study materials are properly shipped, tracked, and maintained across international sites in compliance with import/export regulations and site-specific requirements.

Regulatory Documentation & Compliance:

• Maintain complete and inspection-ready Trial Master Files (TMF) and documentation including informed consent forms (ICFs), safety reports, monitoring logs, and deviations.
• Support audits and regulatory inspections by preparing summaries, responding to findings, and maintaining organized regulatory records.

Cross-Functional Collaboration & Leadership:

• Partner with Regulatory Affairs, Quality, Engineering, and Clinical stakeholders to ensure seamless integration of clinical activities with overall product development.
• Provide regulatory guidance on study design, risk management (e.g., FMEA), and clinical evidence generation to support IDE/PMA pathways.
• Proactively identify trial risks and lead mitigation strategies to ensure timelines, budgets, and compliance targets are met.

Qualifications:

• Bachelor’s degree in a life science, health science, engineering discipline, or other related field; advanced degree preferred.
• 5+ years of experience in regulatory and clinical trial operations, with specific experience in FDA Class III implantable medical devices applications (IDE / PMA) and executing pivotal clinical trials.
• Proven ability to manage multi-site international trials, including site selection, monitoring, and logistics coordination.
• Direct involvement with IDE and PMA submissions.
• Strong understanding of FDA regulations (21 CFR Parts 50, 56, 812), ICH-GCP, ISO 14155, and medical device development lifecycle.
• Familiarity with regulatory submission platforms (e.g., eCTD), regulatory intelligence tools, and document control systems.
• Prior experience managing DMSBs, CROs, and international trial logistics.
• Excellent written and verbal communication skills; proven ability to write regulatory documents and interface with FDA or global agencies.
• Strong leadership, organizational, and project management skills.
• Experience supporting early feasibility studies for implantable devices.
• Working knowledge of EU MDR and Health Canada regulations.