ORO CLEAN CHEMIE SDN BHD Vacancies Regulatory Affairs Executive cum Medical Writer

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.

Job Description

OCC Switzerland is looking for a Regulatory Affairs Executive cum Medical Writer to prepare technical files required for regulatory submission of medical devices.

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.
Our Promise
  • 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.
Good to Know
  • The office is located only 75 meters away from Dang Wangi LRT station. 

Company Overview

Over 45 Years Experience of Researching and Producing Disinfectants
OCC Switzerland is a research-driven manufacturer of high-quality disinfecting and cleaning products. Our slogan ‘killing germs for a safer world’ describes our long-standing mission to support healthcare professionals such as infection control preventionist, doctors, nurses, dentists, veterinarians, beauticians
and other professionals in their continuous battle to prevent the spread of disease. We do so by offering fast-acting, reliable and safe disinfectants.
Since OCC Switzerland’s foundation in 1969, the company has pioneered many breakthroughs in the field of infection control. In 1986, we were the first Swiss company who developed a fast-acting, safe instrument disinfectant which was effective against the Hepatitis B virus (HBV). In 1991, concerned about the high risks of disease transmission associated with the use of turbines, hand-pieces, and contra-angles, OCC Switzerland in collaboration with Dr. Guggenheim, a professor from the University of Zurich, developed a disinfectant to be used in a cutting edge device designed to clean and disinfect this type of instruments. And once again, in 1996, we became the first Swiss dental company to be certified EN 46001 and 93/42/EEC.
More recently, we have developed a new generation of surface disinfectants reducing the alcohol content to less than 50 %. We have done so without compromising the disinfectant’s effectiveness. This new generation of products offers not only full virucidal activity and optimal material compatibility but also significantly reduces the potential for allergic reactions.
Since our early days, our goal has been to manufacture innovative, environmentally sensitive products with a broad spectrum effect and high material compatibility maximizing protection against disease transmission. This philosophy has remained unchanged. However, our product range and services have evolved in response to market and consumer demands. Subsequently, the effectiveness of our disinfectants is continually adapted in order to inactivate emerging pathogenic microorganisms.
We are proud of our past and present achievements; however, what really excites us is the future. We are pursuing the research and development of new products and devices expanding the base of effectiveness, reducing exposure times and increasing compliance with infection control procedures. Our goal is to work toward the day where diseases no longer pose a threat and health care related infections are non-existent. 

How To Apply

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