ORO CLEAN CHEMIE SDN BHD is looking for new potential candidates to fill in for Regulatory Affairs Executive cum Medical Writer position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
Main Duties & Responsibilities
- Prepare and review regulatory submission documents including; but not limited to, Clinical Evaluation Reports, Risk Management Reports and Post-Market Surveillance Reports.
- Liaise with regulatory authorities i.e. Notified Bodies to ensure documents meet current regulatory requirements as well as internal and external guidelines.
- Participate in Post-Market Surveillance (PMS) activities by conducting routine systematic literature reviews, product complaint reviews and other product specific information reviews i.e. review scientific journal articles / literature against specified inclusion / exclusion criteria, extracts relevant information from selected studies, interpret study results and prepare summary reports.
- Plan and conduct usability studies as part of technical documentation compilation.
- Perform any other duties as assigned by the Chief Research Officer or the Executive Management.
- Bachelor’s Degree, Master’s Degree or Doctorate (PhD) in Dentistry, Medical Science, Medicine, Nursing, Pharmacology, Law or relevant work experience.
- Prior experience in preparing Clinical Evaluation Reports, Risk Management Reports or Post-Market Surveillance Reports is an advantage.
- Excellent writing and communication skills in English.
- Must possess high level of accuracy and attention to details.
- Independent and self-driven individual with the ability to prioritize and handle multiple projects simultaneously with a focus on results.
- A self-starter who can work on own initiative without constant supervision.
- Great career development opportunity.
- Modern workplace with excellent facilities.
- Get thoroughly trained.
- Work and learn in one of the fastest growing sectors in medical industry.
- The office is located only 75 meters away from Dang Wangi LRT station.
and other professionals in their continuous battle to prevent the spread of disease. We do so by offering fast-acting, reliable and safe disinfectants.
How To Apply
If you confident and feel that this job is suitable to you, go ahead take your action now.
Hope you find your dream hospital job in Kuala Lumpur.