Sr. International RA Specialist

BD Mexico; Bengaluru; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

BD Bengaluru is seeking a Senior International Regulatory Affairs Specialist to lead regulatory submissions for medical devices worldwide. You will partner with cross-functional teams to collect data, prepare technical documentation, and navigate regulatory requirements across CASAJ, Greater China, LATAM, Canada, and EMEA.

You will develop regulatory strategies, manage lifecycle changes, and proactively mitigate risks to ensure timely approvals and market access.

Qualifications

• Bachelor’s degree in health/life sciences or related field is required.
• Minimum 6 years in medical devices, diagnostic, biologic, or pharmaceutical regulatory affairs.
• Experience with international regulatory registrations across multiple regions (CASAJ, Greater China, LATAM, Canada, EMEA).
• Knowledge of STED/technical files/design dossiers and submission content.
• Proficient with regulatory/quality systems such as SAP, MasterControl, JDE; strong MS Office skills.

Responsibilities

• Lead collecting, compiling, and analyzing country-specific regulatory requirements.
• Drive international registrations according to project plans.
• Prepare and approve technical documentation for submissions.
• Coordinate responses to regulatory authority questions and deficiency letters.
• Develop regulatory strategies for product registrations, renewals, and lifecycle changes.
• Navigate DHF/STED content to support submissions across regions.
• Collaborate with cross-functional teams to gather data requested by authorities.
• Identify regulatory risks and develop mitigation plans to protect timelines.

Skills

Regulatory strategy

Submission planning

Cross-functional collaboration

Leadership

Communication

Problem solving

Education

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

Tools

SAP

MasterControl

JDE

Microsoft Office

Job description

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

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, diagnostic, biologic, and/or pharmaceutical industry, preferably in regulatory affairs.
• 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)
• Technical Expertise
• Developed regulatory strategies and submission pathways for global registrations and lifecycle management activities.
• Prepared regulatory submissions, assessed requirements, and ensured compliance with applicable regulations and standards.
• Evaluated product changes, post-market impacts, and regulatory risks to support market access.
• Maintained regulatory documentation, records, and tracking systems
• 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

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.

Primary Work Location

IND Bengaluru - Technology Campus

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.