Job Description Summary

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.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Primary 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.

About You:

• 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 ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is 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