Staff Specialist Regulatory Affairs

Minimum bachelor’s degree in engineering, Life Sciences, or a related field.
3-5 years of practical experience regulatory affairs, with a focus on SaMD.
Comprehensive understanding of FDA regulations and guidance documents related to SaMD, including; 21st Century Cures Act, 21 CFR Part 820, multifunction Device Products Guidance, clinical Decision Support Software Guidance and SaMD related Guidance.
Knowledge of international regulatory requirements (e.g., FDA QSR, ISO 13485, IEC 62304).
Strong knowledge of risk management processes (ISO 14971) and cybersecurity considerations for medical devices.
Exceptional analytical and problem-solving skills.
Excellent written and verbal communication skills, including regulatory writing.
Strong attention to detail and organizational skills.
Ability to work collaboratively in cross-functional teams.
Proficiency with regulatory databases, document control systems, and project management tools.

Develop and execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents.
Provide regulatory input during the design and development of SaMD, ensuring compliance with applicable standards (e.g., IEC 62304, ISO 14971).
Assess Cloud based multifunction SaMD products to determine compliance with FDA’s guidance on device versus non-device functionality.
Prepare, submit, and manage regulatory submissions for SaMD products.
Evaluate the impact of changes to SaMD functionality and determine whether submissions or notifications are required.
Ensure SaMD compliance with FDA guidance on Clinical Decision Support (CDS) software and other regulatory frameworks.
Work cross functionally in risk assessments and Design Reviews for SaMD products, including evaluation of cybersecurity risks.
Collaborate with R&D, Quality, Marketing, and Regulatory teams to ensure regulatory requirements are met throughout the product lifecycle.
Evaluate software architectural design and identify SaMD functionality.
Provide training and guidance to cross-functional teams on FDA guidance for SaMD and multifunction device products.