BD
Staff Specialist Regulatory Affairs - Becton Dickinson
BD, San Diego, California, United States, 92154
Overview As Staff Specialist Regulatory Affairs, you will have a deep understanding of Risk Based frameworks, Agile SDLC, experience with cross functional team transactions, and various FDA SW related guidance's and industry best practices. The role involves developing and implementing practices for SaMD devices to ensure regulatory compliance, expedition of product clearances and maintain the highest quality standards. Candidates will be expected to work on-site 4 days per week in our San Diego, CA office.
Do you have the skills to fill this role Read the complete details below, and make your application today. Responsibilities
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. Qualifications
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. Preferred Qualifications
Certification in regulatory affairs (e.g., RAC). Experience with cloud-based, or multifunction software systems. Familiarity with post-market surveillance requirements for SaMD. Salary and Benefits Salary ranges shown: $121,100.00 - $199,800.00 USD and $124,700.00 - $205,800.00 USD annual, varies by location and role. Salary ranges may vary for field-based and remote roles. BD prioritizes on-site collaboration to foster creativity, innovation, and problem-solving. For most roles, a minimum of 4 days in-office per week is required. Remote or field-based positions will have different workplace arrangements as indicated in the posting. At BD, employment may be contingent upon proof of full COVID-19 vaccination where required by location, and accommodations will be considered per applicable law. 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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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Do you have the skills to fill this role Read the complete details below, and make your application today. Responsibilities
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. Qualifications
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. Preferred Qualifications
Certification in regulatory affairs (e.g., RAC). Experience with cloud-based, or multifunction software systems. Familiarity with post-market surveillance requirements for SaMD. Salary and Benefits Salary ranges shown: $121,100.00 - $199,800.00 USD and $124,700.00 - $205,800.00 USD annual, varies by location and role. Salary ranges may vary for field-based and remote roles. BD prioritizes on-site collaboration to foster creativity, innovation, and problem-solving. For most roles, a minimum of 4 days in-office per week is required. Remote or field-based positions will have different workplace arrangements as indicated in the posting. At BD, employment may be contingent upon proof of full COVID-19 vaccination where required by location, and accommodations will be considered per applicable law. 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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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