An innovative company in the medical device and clinical research sector is seeking an experienced Safety Officer to support clinical studies and post-market safety activities for investigational and commercial medical devices. The position offers an international working environment with significant involvement in clinical trials.

Position

Safety Officer – Medical Devices & Clinical Trials (m/f/d)

This role is responsible for ensuring patient safety, regulatory compliance, and effective safety oversight throughout clinical investigations and device lifecycle activities.

Key Responsibilities

Regulatory Compliance & Safety Oversight

• Ensure compliance with applicable global regulatory requirements and standards (e.g. EU MDR, FDA regulations, ISO 14155)
• Maintain accurate safety documentation and manage correspondence with regulatory authorities and ethics committees
• Prepare for and participate in safety-related audits and inspections

Safety Reporting & Vigilance

• Oversee the collection, assessment, documentation, and reporting of adverse events and device deficiencies
• Prepare and submit safety and vigilance reports to regulatory authorities and ethics committees
• Manage medical device alerts, field safety notices, and vigilance reporting processes
• Act as the primary contact for safety-related inquiries from investigators, regulatory agencies, and ethics committees

Clinical Trial Support

• Train investigators and clinical trial staff on safety procedures and reporting requirements
• Collaborate with Clinical Affairs and R&D to review and implement safety-related protocol amendments
• Support clinical study execution, including attendance at study procedures where required
• Participate in patient screening meetings and clinical trial preparation activities

Risk Management

• Conduct risk assessments for investigational medical devices and implement mitigation strategies
• Identify and drive continuous improvement opportunities in safety-related processes

Committees & Governance

• Organize, lead, and document safety review meetings with Clinical Events Committees (CEC) and Data Monitoring Committees (DMC)
• Monitor device performance and safety trends, including tracking device-related incidents

Quality, Timelines & Budget

• Support and uphold the Quality Policy and all applicable quality system requirements
• Manage assigned activities in line with agreed timelines and budgets

Your Profile

• Bachelor’s degree in a scientific or clinical discipline, or equivalent relevant clinical experience
• Practical experience in medical devices, ideally in interventional cardiology
• Prior experience in medical device clinical trials, safety reporting, or a closely related field
• Solid understanding of GCP, regulatory compliance, and medical device clinical trial regulations (e.g. FDA CFR, ISO 14155)
• Experience in medical device safety and vigilance reporting
• Excellent communication skills in English; additional languages are a plus
• Confident working independently while collaborating effectively within cross-functional teams
• Experience in training, presenting, or teaching clinical or medical content

Flexibility & Travel

• Willingness to travel up to 50%
• Flexibility to accommodate non-standard working hours and extensive travel schedules