Company Confidential Vacancies CLINICAL & REGULATORY SPECIALIST

Company Confidential is looking for new potential candidates to fill in for CLINICAL & REGULATORY SPECIALIST position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.

Job Description

  • To coordinate and manage all clinical trials for company's range of products.
  • To coordinate compilation of data, documentation and submission of reports to authorities related to clinical trials conducted in Malaysia.
  • Serves as main contact for investigators, sponsors, government agencies, and the IRB.
  • Collaborate on development of clinical study documents (e.g., Investigator Brochure, protocols, case report forms).
  • Responsible for operational oversight of the project to include creating and monitoring timelines and keeping the project compliant and on track.
  • Assist in the preparation and review of key study regulatory documents, submissions, and annual reports.
  • To monitor and compile all post market information including PMCF and evaluation of products.
  • To manage all records and monitor effectiveness of workshops, CME and user training related activities.
  • To coordinate new item request and manage evaluation and follow up related to new products in the market.
  • Manage product complaints and other user feedback via vigilance system.
  • Manage and ensure upkeep of all GDPMD related documentation and audits.
  • Manage and coordinate product registration with Medical Devices Authority.
  • Other relevant assignments that shall be assigned by management from time-to-time.
  • Candidate must possess at least a degree in Life Science, Nursing or equivalent.
  • Experience in handling clinical research or regulatory will be an advantage.
  • Knowledge in ISO 13485.
  • Good written and spoken in English.
  • Willing to travel and possess own transport.
  • Able to work independently with minimum supervision.
  • Proactive and passionate about healthcare industry and being patient centric.

Company Overview

We are a wholly owned Malaysian company engaged in design, manufacturing and distribution of medical products. The company currently has well established international markets which are rapidly growing. We are now seeking dynamic individuals to join us in our organisation.

How To Apply

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