Boston Scientific Regulatory Affairs Specialist 

Malaysia, Penang 

898093862

Job Responsibilities:

• Review and assessment of product and manufacturing changes for compliance with applicable regulations.
• Collaboration with international regulatory counterparts to provide deliverables and ensure compliance to local regulations when developing regulatory strategies and assessing changes.
• Support in Regulatory body audits, such as FDA, BSI, DEKRA.
• Liaise with both middle and senior management on any regulatory issues relating to their area.
• Maintain information in any internal regulatory databases.
• Support and maintain Quality initiatives in accordance with BSC Quality Policy.
• Continuously assess ways to improve Quality.
• Administrative support tasks (e.g., submission support).

Job Requirements:

• Candidate require process at least Bachelor’s degree in a scientific, technical or related discipline.
• Minimum of one (1) year Regulatory Affairs or related experience at Medical Device industry.
• Has general knowledge of current and proposed US and EU regulations for medical devices.
• Familiar with ISO 13485 and MDSAP requirements.
• Ability to manage several projects simultaneously with keen attention to detail.
• Ability to review, collate, describe, and summarize scientific and technical data.
• Ability to work independently with minimal supervision.
• General knowledge of product development process and design control.
• Proficiency in the use of computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat.
• Effective written, oral communication, technical writing and editing skills.
• Effective research and analytical skills.
• Team player with good interpersonal skills.