Role Description

The Senior Regulatory Expert - Medical Devices will oversee and define roadmap for the global regulatory submissions for US Class I and II and EU Class A, B and C in vitro diagnostic medical devices to global regulatory agencies and/or to commercial partners.

• Oversee and define roadmap for global regulatory submissions for US Class I and II and EU Class A, B and C in vitro diagnostic medical devices.
• Develop and implement strategic frameworks for compliance requirements in various regions including USA, EU, Canada, UK, Switzerland, and others.
• Provide regulatory insights and action plans to cross-functional teams to ensure compliance with regulations such as IVDR, FDA 21 CFR 820, and ISO 13485:2016.
• Independently author, compile, and maintain technical files and regulatory documentation for timely registrations and renewals.
• Review and approve quality management system documentation related to post market surveillance and risk management.
• Respond to regulatory inquiries and participate in inspections by authorities and notified bodies.
• Implement strategic frameworks for assessing regulatory implications of engineering changes.
• Monitor and analyze global regulatory developments and lead regulatory surveillance activities.
• Manage regulatory review process for labeling materials ensuring compliance with global regulations.
• Provide regulatory assessment for new product development initiatives.
• Manage recall or notification actions and ensure effective execution of regulatory vigilance reporting.
• Mentor junior team members to support their onboarding and development.

Qualifications

• Bachelor of Science degree in pharmacy, biology, chemistry, pharmacology, chemical engineering, or a closely related field.
• At least seven (7) years of progressively more responsible work experience in global regulatory strategies for in vitro diagnostic medical devices.

Requirements

• Demonstrated knowledge of medical device or in-vitro diagnostics regulatory compliance.
• Ability to author complex regulatory technical documentation for submission to competent authorities.
• Experience utilizing software tools for Robotic Process Automation (RPA) solutions.
• Ability to conduct regulatory impact assessments and identify regulatory risks early in the process.

Benefits

• Generous benefits packages.