B Braun Medical Supplies Sdn Bhd Vacancies Senior Regulatory Affairs Executive

B Braun Medical Supplies Sdn Bhd is looking for new potential candidates to fill in for Senior Regulatory Affairs Executive position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.

Job Description

Job Function:
  • Coordinate post market activities including product complaint management, mandatory problem reporting, product recall, field safety corrective action and adverse event reporting, ensuring regulatory compliance within the company and relevant government bodies.
  • Assist in the implementation of Integrated Management System (IMS) and GDPMD.
  • Assist in pharmaceutical/medical device registration and regulatory compliance with relevant government bodies.
  • Assist in relevant administrative jobs related to the regulatory affairs and quality assurance matters.
  • Product Complaints Management
  • Mandatory Problem Reporting (MPR)
  • Coordinate Product Recall
  • Coordinate Field Safety Corrective Action
  • Update B. Braun Medical Supplies (BMS) adverse event reporting (MDR/Recalls/FSCAs) to internal and/or external stakeholders
  • GDPMD audit liaison
  • Maintain and update of IMS GxP docs
  • Assist in regulatory filing, maintenance and documentation for pharmaceutical and medical device.
  • Conduct monthly orientation in regards to post market related activities and IMS GxP docs.
Requirements :
  • A Bachelor’s degree, preferably in the Life Science-related field
  • Minimum 3 years’ experience in Medical or Pharmaceutical product registration
  • Experience in quality management or regulatory compliance activities
  • Good communication skills in English and Bahasa Malaysia (both verbal and written)
  • Experience liaising with the Ministry of Health and other health regulatory bodies
  • Proficient in Microsoft Office
  • Detail-oriented and able to meet target timelines

Company Overview

We are convinced that you are an important part of our future. Hopefully, we're also a part of yours! At B. Braun, we protect and improve the health of people worldwide. That is our shared vision.  In sales, we are guided by our customer’s requirements. The ones we know, and the ones we don’t know. You recognize potential, hold constructive discussions and are familiar with people and figures. We would like to strengthen our business with you in the long term. We encourage entrepreneurial thinking and provide the framework for bold ideas, proactive approaches and open and fair communication. This is how we build long-term relationships – both with our customers and with you. That's Sharing Expertise. Curious? Then start your time with B. Braun.

How To Apply

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