Job Description

The Senior Global Regulatory Affairs Specialist is responsible for developing and implementing regulatory strategies to support the submission, filing, and registration of medical devices in general surgery, cardiac surgery, and dermatology across global markets. This role provides strategic regulatory guidance within cross-functional teams, manages interactions with global health authorities, and ensures compliance with FDA QSR, EU MDR, ISO 13485, and other international standards.

• Develop and implement regulatory strategies for clinical and non-significant risk medical devices, identifying risks and optimizing compliance with global standards.
• Prepare and submit international regulatory documents, including Technical Files and Design Dossiers for CE Marking, as well as FDA submissions (510(k), IDE, PMA).
• Oversee product registration submissions, ensuring alignment with business objectives and regulatory standards.
• Interact with regulatory agencies to expedite approvals and manage post-market surveillance, including adverse event reporting.
• Collaborate with clinical operations to align study results with regulatory requirements and ensure technical documentation supports product approvals.
• Serve as the regulatory representative on cross-functional teams, advising on product changes, labeling, and risk management.
• Maintain regulatory procedures, support product lifecycle management, and write regulatory justifications for design changes.

• Bachelor’s degree in engineering, life sciences, or a related discipline.
• 5+ years in Global Regulatory Affairs within medical devices or biotechnology, with expertise in general/plastic surgery, cardiology, or dermatology preferred.
• Experience with Notified Bodies, Competent Authorities, and clinical registration databases.
• Proficiency with EU MDR, FDA QSR, ISO 13485, and lifecycle management for high-risk devices.
• Strong project management and critical thinking skills, with proven ability to manage complex submissions.
• Excellent written and verbal communication skills and proficiency in Microsoft Office.
• Ability to travel up to 10%, including occasional overnight and international trips; able to lift 10-15 pounds.

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