Sr. Regulatory Affairs Specialist

Becton, Dickinson and Company; Kuala Lumpur; On-site; MYR 60,000 - 100,000; Full time

Job summary

Becton, Dickinson and Company in Kuala Lumpur seeks a Sr. Regulatory Affairs Specialist to ensure SEA regulatory compliance for APM products.

The role involves preparing, submitting, and maintaining regulatory submissions and guiding teams to enable market access. The successful candidate will manage regulatory approvals, review labeling and change controls, and monitor evolving SEA regulations to shape regulatory strategies for new product introductions and modifications.

Qualifications

• 3–5 years of regulatory affairs experience in medical devices.
• Experience preparing and submitting regulatory applications.
• Excellent written and verbal communication; ability to articulate complex regulatory requirements clearly.
• Ability to work independently and collaborate with cross-functional teams.

Responsibilities

• Prepare, compile, and submit regulatory applications for SEA region.
• Manage and maintain existing regulatory approvals, licenses, and registrations; ensure renewals and updates.
• Review and approve product labeling, promotional materials, and change control documents for regulatory compliance.
• Assess regulatory impact of product changes and determine need for new/updated submissions.
• Interface with distributors, consultants, and regulatory agencies during submissions, inquiries, and audits.
• Monitor SEA regulations, standards, and guidance relevant to BD products; implement regulatory strategies for new products and changes.
• Maintain accurate regulatory documentation and databases.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory submissions

Communication

Education

Bachelor's degree in Life Sciences or related

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 its 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 The Sr. Regulatory Affairs Specialist at Becton, Dickinson and Company plays a crucial role in ensuring APM products comply with regulatory requirements in SEA. This position involves preparing, submitting, and maintaining regulatory submissions, as well as providing guidance to teams to facilitate product changes and market access.

Job Responsibilities

• Prepare, compile, and submit regulatory applications for SEA region.
• Manage and maintain existing regulatory approvals, licenses, and registrations, ensuring timely renewals and updates.
• Review and approve product labeling, promotional materials, and change control documents for regulatory compliance.
• Assess the regulatory impact of product changes and determine the need for new or updated submissions.
• Interface with distributors, consultants, and regulatory agencies during submissions, inquiries, and audits.
• Monitor and interpret new and evolving SEA regulations, standards, and guidance documents relevant to BD products.
• Develop and implement regulatory strategies for new product introductions and existing product modifications.
• Maintain accurate and organized regulatory documentation and databases.

Job Qualifications

• Minimum of 3-5 years of experience in Regulatory Affairs within the medical device.
• Experience in preparing and submitting regulatory applications
• Excellent written and verbal communication skills, with the ability to articulate complex regulatory requirements clearly.
• Ability to work independently and as part of a cross-functional team.

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.

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 Location MYS Kuala Lumpur - Damansara Heights Additional Locations Work Shift BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.