Job Description

Overview As Staff Specialist Regulatory Affairs, you will have a deep understanding of risk-based frameworks, Agile SDLC, cross-functional team transactions, and various FDA software-related guidance and industry best practices. The role involves developing and implementing practices for SaMD devices to ensure regulatory compliance, expedites product clearances, and maintains the highest quality standards. This position requires on-site work in our San Diego, CA office four days per week. Primary Responsibilities Develop and execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents. Provide regulatory input during 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 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. About You This position is specifically focused on regulatory affairs for Software as a Medical Device (SaMD) products. The candidate will need deep expertise in FDA regulations, risk-based frameworks, and Agile software development lifecycle methodologies to ensure BD's software medical products meet all regulatory requirements. Exceptional analytical and problem-solving abilities Excellent written and verbal communication skills, especially regulatory writing Strong attention to detail and organizational skills Collaborative team player Proficiency with regulatory databases and document control systems Minimum Qualifications Bachelor's degree minimum in engineering, life sciences, or related field 3–5 years of practical regulatory affairs experience with SaMD focus Comprehensive understanding of FDA regulations for SaMD, including: 21st Century Cures Act 21 CFR Part 820 Multifunction Device Products Guidance Clinical Decision Support Software Guidance Other SaMD-related guidance documents Knowledge of international regulatory requirements (FDA QSR, ISO 13485, IEC 62304) Strong knowledge of risk management processes (ISO 14971) and cybersecurity for medical devices Preferred Qualifications Regulatory Affairs Certification (RAC) Experience with cloud-based or multifunction software systems Salary Information Salary ranges have been implemented to reward associates fairly and competitively, ranging from entry level to experts in their field. Salary offers are based on experience, education, skills, and actual work location. Salary ranges may vary for field-based and remote roles.

$121,100.00 - $199,800.00 USD

Work Location and Schedule On-site collaboration is prioritized. For most roles, a minimum of 4 days in-office presence per week is required. Remote or field-based positions will have different arrangements as noted in the posting. Why Join Us? A career at BD means being part of a team that values your opinions and contributions, encouraging you to bring your authentic self to work. We help each other be great, do what’s right, hold each other accountable, and learn and improve every day. BD is a place to learn, grow, and thrive while making a meaningful impact on health. Equal Opportunity Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military status, or any other protected status. Location: San Diego, CA area. For more information, visit our Careers Site. #J-18808-Ljbffr BD Nogales Norte

Job Tags

Work at office, Remote work,

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