Job Description
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.