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Boston Scientific Regulatory Affairs Specialist 
Malaysia, Penang 
898093862

29.11.2024

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.