Senior International Regulatory Affairs Specialist
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Job summary
BD is seeking a Senior International Regulatory Affairs Specialist to lead worldwide regulatory submissions for medical devices, partnering with cross-functional teams to ensure timely approvals.
The role requires a Bachelor’s in health or life sciences, 6+ years in medical devices, and hands-on experience with global registrations, DHF/STED, and regulatory strategies.
Qualifications
- Bachelor’s degree in health/science fields or related area.
- 6+ years in medical device regulatory affairs or related area.
- Experience with international registrations and data packages.
- Familiar with DHF/STED and submission formats.
- Proficient in regulatory systems and Microsoft Office tools.
Responsibilities
- Lead collecting, compiling, and analyzing country-specific regulatory requirements.
- Drive international registrations per project plan and prepare submissions.
- Coordinate with cross-functional teams to respond to regulatory requests.
- Develop regulatory strategies for product registrations and lifecycle changes.
- Assess regulatory risks and create mitigation plans.
Education
Tools
Job description
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.
Responsibilities:
The Senior International Regulatory Affairs Specialist will be responsible for partnering in the preparation and approval of regulatory submissions of medical devices worldwide.
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.
- Navigates, interprets, and applies Design History File (DHF)/Technical File (STED) content to assess regional applicability and support international regulatory submissions.
- Develops and executes regulatory strategies for product registrations, renewals, and lifecycle changes to support business objectives and market access requirements.
- Proactively identifies regulatory risks, assesses potential business impact, develops mitigation plans, and escalates critical issues in a timely manner to enable effective decision-making and maintain project timelines.
- Navigates and works effectively across multiple quality management systems, regulatory processes, and regional requirements to ensure timely execution of registrations
- 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
- Obtains Regulatory Certificates such as CFGs and FSCs
- Generate and coordinate responses to regulatory authority questions and deficiency letters in collaboration with internal subject matter experts.
- Support global product lifecycle activities, including renewals, labeling updates, and change assessments, ensuring ongoing compliance in assigned markets.
Education and Experience:
- Required Education and Experience
- Bachelor's degree in health science, life science, biology, chemistry, bio-engineering, microbiology, or a related field.
- Minimum 6 years of experience in the medical device industry
- Experience with international regulatory product registrations and assessments across multiple regions, such as CASAJ, Greater China, LATAM, Canada, and EMEA.
- Working knowledge of STED, technical files, design dossiers, and required submission structure and content.
- Digital literacy with regulatory, quality, and business systems/tools such as SAP, MasterControl, JDE, and Microsoft tools.
- Microsoft Office Proficiency( AI Copilot, Agent, Word, Excel, PowerPoint, PowerBi)
- Experience navigating Design History File (DHF) and reviewing Design Verification reports to support regulatory assessments, registrations, submissions, or product changes
- Technical Expertise
- Maintained regulatory documentation, records, and tracking systems.
- Evaluated product changes, post-market impacts, and regulatory risks to support market access.
- Prepared regulatory submissions, assessed requirements, and ensured compliance with applicable regulations and standards.
- Developed regulatory strategies and submission pathways for global registrations and lifecycle management activities.
In addition to technical expertise, the position requires the following core professional competencies and soft skills:
- Decisive Leadership
- Exercised sound regulatory judgment and managed competing priorities to achieve regulatory objectives.
- Identified risks, assessed impacts, and provided recommendations to support business decisions.
- Communicated regulatory strategies, issues, and potential impacts to stakeholders and leadership.
- Foster Teamwork
- Collaborated effectively with regional, cross-functional, and business partners to deliver regulatory outcomes.
- Built strong working relationships and supported a collaborative team environment.
- Coordinated activities and communicated proactively to ensure successful execution of deliverables.
- Improve Continuously
- Drove improvements in regulatory processes, submission quality, compliance, and operational efficiency.
- Expanded regulatory knowledge and applied best practices to support continuous improvement.
- Adapted to feedback and maintained high-quality execution under tight deadlines.
- Communicate Clearly
- Communicated complex regulatory information clearly to technical and non-technical audiences.
- Delivered concise status updates, presentations, and regulatory recommendations.
- Facilitated alignment through effective listening, documentation, and stakeholder engagement.
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.
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
- 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)
- Jury and Witness Duty Leave
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
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USA NJ - Franklin Lakes
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
$110,200.00 - $176,400.00 USD Annual
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