Sr. Regulatory Affairs Specialist

BD; Kampung Malaysia Tambahan; On-site; MYR 120,000 - 180,000; Full time

Job summary

BD in Malaysia is seeking a Sr. Regulatory Affairs Specialist to ensure SEA medical devices comply with regulatory requirements. You will prepare, submit, and maintain regulatory submissions and guide cross-functional teams to achieve market access.

The role involves managing registrations, review of labeling and promotional materials, and monitoring SEA regulatory changes. Collaboration with distributors, consultants, and agencies is essential for successful submissions.

Qualifications

• Minimum 3-5 years of regulatory affairs experience in medical devices.
• Experience in preparing and submitting regulatory applications.
• Strong communication and cross-functional collaboration skills.

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.

Skills

Regulatory submissions

Regulatory affairs

Communication skills

Team collaboration

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

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.

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

MYS Kuala Lumpur - Damansara Heights