Job Description Summary

The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset.
The Senior International Regulatory Affairs Specialist will execute regulatory project timelines and manage the processes and systems designed to ensure that all regulatory requirements are met for a location change (re-location) of a production facility and Legal Manufacturer address change.
The Senior International Regulatory Affairs Specialist will be responsible for partnering in the preparation and approval of regulatory submissions of medical devices worldwide.

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. 

Job Responsibilities:

• Leads collecting, compiling, and analyzing, country specific regulatory requirements 

• Drives international registrations according to project plan 

• Reviews and approves technical documentation to ensure required information and data for regulatory submissions are included. 

• Prepares and/or compiles information required by international regulatory associates to register or maintain registration of products in international regions. 

• Collaborates with cross-functional teams for preparation of additional data/information requested by notified body/ regulatory agencies and prepares appropriate responses to all requests. 

• Ensures submission tasks related to Change Control are completed 

• Compiles and communicates Regulatory impact assessments, submission & approval status world-wide to Supply Chain to ensure regulatory compliance and business continuity 

• Assists in developing, maintaining, regulatory strategies, reporting regulatory submission & approval status dashboard & metrics. 

• Obtains Regulatory Certificates such as CFGs, FSCs 

Education and Experience:

• Bachelor's degree in health science or life science field (biology, chemistry, bio-engineering, microbiology) or related field. 

• Minimum 5-10 years’ experience in the device/diagnostic, biologic and/or pharmaceutical industry in regulatory affairs 

• Experience with several international countries RA product registration/assessment (CASAJ, Gr. China, LATAM, Canada, EMEA)  

• Proven ability to interpret medical device regulatory requirements, Good Laboratory Practices (GLP), and Quality System Regulations (QSR) 

• Lead, influence and apply feedback from cross functional teams (B2B, Regional and Country RA associates, MDS Business Platforms , and Regulatory bodies). 

• Digital literacy (SAP, Excel, Pivot Tables, PowerPoint, Access, Agile, Regulatory e-Systems) 

• Project management experience highly preferred; experience with prioritizing multiple tasks and driving results. 

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.

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: 

• Annual Bonus

• Potential Discretionary LTI Bonus

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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 financial aid and 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

• Adoption assistance  

• Backup day care and eldercare  

• Support for neurodivergent adults, children, and caregivers  

• Caregiving assistance for 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)  

• Jury and Witness Duty Leave 

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

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

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate 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 or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information