Regulatory Affairs Specialist

Regulatory Affairs Specialist Becton Dickinson & Company Franklin Lakes, NJ We are the people who give possibilities purpose 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. 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. The Regulatory Affairs Specialist at Becton, Dickinson and Company is responsible for supporting the preparation and submission of regulatory documents to health authorities, ensuring compliance with global regulations for medical devices. Job Responsibilities: Prepare and submit regulatory filings (e.g., 510(k)s, Technical Files, Design Dossiers, PMAs) to global health authorities in accordance with applicable regulations and company procedures. Review and assess proposed product changes for regulatory impact and ensure timely updates to existing regulatory submissions. Support the development and maintenance of regulatory strategies for new product development and existing product lines. Collaborate with cross-functional teams (e.g., R&D, Quality, Marketing, Clinical) to ensure regulatory requirements are integrated throughout the product lifecycle. Participate in internal and external audits and inspections, providing regulatory expertise and documentation as needed. Monitor and interpret new and evolving global regulations, standards, and guidance documents relevant to medical devices. Maintain accurate and organized regulatory documentation and databases. Assist in responding to regulatory agency inquiries and requests for information. Provide regulatory support for post-market surveillance activities, including adverse event reporting and recall support. Job Qualifications: Bachelor's degree in a scientific discipline (e.g., Biomedical Engineering, Biology, Chemistry, Pharmacy) or related field. 1+ years of experience in medical device industry. Demonstrated understanding of global medical device regulations (e.g., FDA 21 CFR Part 820, EU MDR/IVDR, Health Canada, TGA). Experience with preparing and submitting regulatory filings (e.g., 510(k)s, CE Mark Technical Files). Strong analytical, problem-solving, and decision-making skills. Excellent written and verbal communication skills, with attention to detail. Ability to work independently and as part of a team in a fast-paced environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). RAC certification is a plus. 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? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. 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 health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit https://bd.com/careers At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role: Health and Well-being Benefits Medical coverage, Health Savings Accounts, Flexible Spending Accounts, Dental coverage, Vision coverage, Hospital Care Insurance, Critical Illness Insurance, Accidental Injury Insurance, Life and AD&D insurance, Short-term disability coverage, Long-term disability insurance, Long-term care with life insurance. Other Well-being Resources Anxiety management program, wellness incentives, sleep improvement program, diabetes management program, virtual physical therapy, emotional/mental health support programs, weight management programs, gastrointestinal health program, substance use management program, musculoskeletal surgery, cancer treatment, and bariatric surgery benefit. Retirement and Financial Well-being BD 401(k) Plan, BD Deferred Compensation and Restoration Plan, 529 College Savings Plan, financial counseling, Baxter Credit Union (BCU), Daily Pay, college financialaidand application guidance. Life Balance Programs Paid time off (PTO), including all required State leaves, educational assistance/tuition reimbursement, MetLife Legal Plan, group auto and home insurance, pet insurance, commuter benefits, discounts on products and services, Academic Achievement Scholarship, Service Recognition Awards, employer matching donation, workplace accommodations. Other Life Balance Programs Adoptionassistance, backup day care and eldercare, support for neurodivergent adults, children, and caregivers, caregivingassistancefor elderly and special needs individuals, Employee Assistance Program (EAP), paid parental leave, support for fertility, birthing, postpartum, and age-related hormonal changes. Leave Programs Bereavement leaves, Military leave, Personal leave, Family and Medical Leave (FML),Juryand Witness Duty Leave. 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. 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 Optional Skills . Primary Work LocationUSA NJ - Franklin Lakes Additional Locations 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. You can learn more on our career site under "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 $84,300.00 - $138,900.00 USD Annual

Salary : $84,300 - $138,900