Senior Regulatory Affairs Specialist

🔥 0 minutes ago

🇲🇾 Malaysia – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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BD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1897

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $24M Grant on 2020-07

Healthcare • Manufacturing • Healthcare Insurance

BD (Becton, Dickinson and Company) is a global medical technology company dedicated to advancing the world of health. It focuses on developing innovative technologies, services, and solutions to improve safety and efficiency in healthcare. BD offers a wide range of products including medication management solutions, surgical solutions, cervical cancer screening, drug delivery systems, and laboratory services. The company is also involved in infection risk management and provides advanced clinical insights to enhance patient outcomes. With a commitment to global health sustainability and social investing, BD is a leader in healthcare technology and services worldwide.

📋 Description

• Prepare, compile, and submit regulatory applications for the SEA region • Manage and maintain regulatory approvals, licenses, and registrations, including 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 requirements 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 • Develop and implement regulatory strategies for new product introductions and existing product modifications • Maintain accurate and organized regulatory documentation and databases

🎯 Requirements

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

🏖️ Benefits

• Face-to-face collaboration culture • Learning, growth, and development opportunities • Equal opportunity employment