Staff Regulatory Affairs Specialist

Becton Dickinson NA; San Diego (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

Becton, Dickinson and Company (BD) seeks a Regulatory Affairs professional to lead and support regulatory submissions for medical devices across the U.S., EU, and international markets. You will collaborate with R&D, QA, Manufacturing and marketing to ensure compliance throughout the product lifecycle.

The role requires independent analysis of technical data, development of regulatory strategies, and effective communication with FDA and other agencies.

Qualifications

• Minimum 5 years of Regulatory Affairs experience in the medical device industry, preferably with FDA Class II and/or Class III devices.
• Experience preparing and completing regulatory submissions (PMA, 510(k), IDE) to FDA and other regulatory agencies.
• Ability to evaluate technical/clinical data and resolve regulatory issues; knowledge of V&V, risk management, usability, reprocessing, biocompatibility, and software development.

Responsibilities

• Coordinate, prepare, and follow up with FDA Premarket Notification 510(k) submissions in a timely manner.
• Act as liaison with FDA regarding product clearance.
• Assess necessity for submitting a 510(k) application for proposed device changes.
• Prepare internal "Non-Filing Justifications" (U.S.) for changes that do not require a 510(k) submission.
• Prepare technical files / dossiers for International Registrations with input from R&D, Quality, Manufacturing, etc.
• Review and approve labeling, promotional and advertising materials to ensure regulatory compliance.
• Represent RA in product life cycle development teams by reviewing, approving, and completing requirements.
• Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary.
• Represent RA in design teams and projects by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.
• Support International Registrations as it relates to product changes and/or new product launches.
• Responsible for writing and updating SOPs, WI, and policies on an as-needed basis.
• Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers.
• May provide leadership by assigning work and resolving complex problems.

Skills

Regulatory submissions (PMA, 510(k), 1

Cross-functional collaboration

Regulatory strategy development

Education

Bachelor's degree in Regulatory Science, Biomedical, Pharmaceutical, or related scientific field

Job description

We are the people who give possibilities purposeBD 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.

Job Description

This position is responsible for preparing and executing regulatory submissions required to obtain and maintain market authorization for new and modified medical devices in the United States, Europe, and other international markets. The role leads and supports a broad range of regulatory affairs activities, including the development, implementation, and management of regulatory processes, procedures, and systems that ensure compliance with applicable global regulations throughout the product lifecycle. The position partners closely with cross-functional teams to ensure that product development activities and design changes comply with applicable regulatory requirements while supporting business objectives and product commercialization strategies. Key responsibilities include ensuring regulatory requirements are appropriately addressed across verification and validation, risk management and usability, reprocessing and biocompatibility, and software development activities. The role requires independent analysis and resolution of complex regulatory issues, evaluation of technical and clinical data, application of risk-based decision-making, and development of regulatory strategies that support product development, lifecycle management, and organizational goals.

Responsibilities

• Coordinate, prepare, and follow up with FDA Premarket Notification 510(k) submissions in a timely manner.
• Act as liaison with FDA regarding product clearance.
• Assess necessity for submitting a 510(k) application for proposed device changes.
• Prepare internal "Non-Filing Justifications" (U.S.) for changes that do not require a 510(k) submission.
• Prepare technical files / dossiers for International Registrations with appropriate input from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
• Review and approve labeling, promotional and advertising materials to ensure regulatory compliance.
• Represent RA in product life cycle development teams by reviewing, approving, and completing requirements.
• Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary.
• Represent RA in design teams and projects by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.
• Support International Registrations as it relates to product changes and/or new product launches.
• Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
• Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers.
• May provide leadership by assigning work and resolving complex problems.

Minimum Requirement

Bachelor's degree in Regulatory Science, Biomedical, Pharmaceutical, or related scientific field (or equivalent)Minimum of 5 years of Regulatory Affairs experience in the medical device industry, preferably with FDA Class II and/or Class III devices

Required Experience

Medical device regulatory submission experience for the U.S., Europe, and/or international markets. Demonstrated success in the preparation and completion (including negotiations) of regulatory submissions (PMA, 510(k), IDE) to FDA and other regulatory agencies Experience supporting product development, design changes, and product lifecycle management. Ability to evaluate technical/clinical data and independently resolve complex regulatory issues. Knowledge of regulatory requirements across V&V, risk management, usability, reprocessing, biocompatibility, and software development. Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure. Strong cross-functional communication and risk-based regulatory strategy development.

Workplace Information

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers .

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Required Skills

Primary Work Location

USA CA - San Diego Bldg A&B

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.

Benefits

• Health & Well-being: Medical, dental, vision, health savings and flexible spending accounts, life and disability insurance, wellness resources, mental health support, and disease management programs.
• Retirement & Financial Well-being: 401(k), deferred compensation programs, financial counseling, DailyPay, and educational savings resources.
• Work-Life Balance & Family Support: Paid time off, company holidays, educational assistance, parental leave, adoption assistance, backup care, caregiving support, employee assistance programs, commuter benefits, pet insurance, legal services, and associate discount programs.
• Leave Programs: Bereavement, military, personal, family and medical leave, and jury duty leave.

Additional details regarding benefits and well-being programs can be found in Our Commitment to You .

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information $129,600.00 - $207,400.00 USD Annual