Regulatory Affairs Specialist

🔥 0 minutes ago

🇲🇾 Malaysia – Remote

⏰ Full Time

🟢 Junior

🚔 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

• Work collaboratively with project teams to update regulatory technical documentation • Maintain existing technical documentation according to IVDR (EU) 2017/746 requirements • Report on file status, including identification and remediation of gaps • Conduct regulatory assessments for product and process changes • Develop and update internal procedures and processes • Develop and update files to fulfill UKCA regulations • Support CE marking activities, including preparation and submission of product technical files • Review product labeling • Support international registrations and product release-to-market activities • Perform other Regulatory Affairs duties and assignments as required

🎯 Requirements

• B.S. degree in health science or life science field (biomedical engineering, engineering, computer science, biology, medical technology, etc.) • 1-2 years of experience in medical devices required, with experience in Regulatory Affairs, Quality or R&D • Knowledge and experience with regulatory requirements for medical devices, including CE mark technical files and design dossiers • Knowledge of regulatory requirements for in vitro diagnostic devices • Ability to handle multiple tasks with attention to detail and limited supervision • Excellent oral and written communication skills, analytical thinking and technical writing • Ability to work on cross-functional teams and manage several parallel deliverables • Excellent organization and prioritization skills, including ability to facilitate and document • Ability to identify areas of concern in complex projects and manage changes • Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork • Computer literacy, including Information Systems, Microsoft Word, Excel and PowerPoint

🏖️ Benefits

• Opportunity to learn, grow and thrive • Face-to-face collaboration supporting learning, progress and success • Equal opportunity employment