SEA Regulatory Affairs Specialist: MedTech Compliance

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

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.