Job Description

Position Overview

We are seeking a seasoned regulatory affairs professional to lead the post-market compliance operations within our regulatory team. This role focuses on overseeing critical post-market functions including incident reporting, global compliance submissions, and product surveillance. The successful candidate will be responsible for managing a team, engaging with international regulatory bodies, and driving continuous improvement in regulatory processes.

Key Responsibilities

Post-Market Compliance & Surveillance

• Lead all post-market surveillance activities, ensuring compliance with regional and international regulatory standards.
• Review and approve documentation related to adverse event reporting, device malfunctions, and corrective actions.
• Oversee development and execution of post-market surveillance strategies and risk assessments.
• Coordinate and conduct health hazard evaluations in collaboration with cross-functional subject matter experts.
• Ensure proper execution and closure of field actions, including recalls and safety notices.
• Stay current with evolving global regulatory standards, updating internal procedures accordingly.

Regulatory Reporting & Monitoring

• Ensure timely and accurate submission of Medical Device Reports (MDRs), vigilance reports, and other compliance filings.
• Manage product registrations, including UDI programs and global device databases (e.g., EUDAMED, GUIDID).
• Maintain robust systems for tracking and trending reportable events to support operational insights and quality improvements.
• Support audits and inspections by regulatory bodies, providing documentation and team oversight as needed.

Team Leadership & Development

• Supervise and mentor a regulatory team focused on post-market activities, providing training and growth opportunities.
• Resolve operational issues and drive process improvements across the compliance function.
• Represent the regulatory function in cross-functional teams and ensure effective collaboration across departments.
• Oversee employee onboarding, performance evaluations, and talent development initiatives.

Qualifications

Education & Experience

• Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline is required.
• 8–10 years of experience in regulatory affairs or quality assurance within the medical device, diagnostics, or pharmaceutical sector.
• At least 5 years in a leadership or supervisory capacity.
• Regulatory Affairs Certification or similar credentials are highly preferred.

Skills & Competencies

• Deep understanding of FDA and international medical device regulatory requirements.
• Proven ability to manage regulatory processes and lead team operations.
• Strong analytical, organizational, and communication skills.
• Experience collaborating across functional teams in a highly regulated environment.
• Ability to synthesize technical information and communicate effectively with stakeholders at all levels.

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