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Jobs or company...

Medical Device Regulatory Affairs Specialist

Salary undisclosed

Apply on

JobStreetMY
Original
Simplified

JOB DESCRIPTION

  • Qualtek Consulting Sdn. Bhd. is currently looking for a Medical Device Regulatory Affairs Specialist
  • The candidate will be mainly responsible to handle and supporting the immediate supervisor in executing product registration activities. He shall also assist in catering to the in-country representation needs of clients.
  • Medical device related regulations and certification services in different countries: Medical Device Quality System Management, Pre-market regulatory inspection and registration, testing verification and clinical evaluation, etc.
  • Preparation of technical documents for international medical device regulations

KEY RESPONSIBILITIES

  • Ensures effective presentation of technical dossier to regulatory agencies.
  • Manages product certificates and performs other tasks related to in-country representation of principals.
  • Ensures our activities accord with GDPMD.
  • Develops & maintains updated knowledge of applicable international/regional and local regulations and guidelines.
  • Performs other duties and responsibilities as may be assigned from time to time.

JOB REQUIREMENTS

  • Bachelor’s degree in Science/ Pharmacy/ Bioengineering/ Biotech/ Biochemical/ Electrical Engineering or related field from a reputable university
  • Minimum 1 years of regulatory experience, preferably in the pharmaceutical or Medical device industry
  • Proficient in English and Good in Bahasa Malaysia
  • Welcome fresh graduates

BENEFITS

  • Salary : Negotiable
  • EPF, EIS, SOCSO included
  • Dress Code : Business Casual
  • Benefits : Medical, Bonus, Miscellaneous allowance
  • Working Hours: Mondays-Fridays 9am – 6pm
  • Location: 3 mins walk to LRT station

======================================
Qualtek (Qualtech Group) is an Asia Medical Device Consulting and Clinical Trial (CRO) Company founded in 2000. Since its establishment, Qualtek has built its own culture to have integrity, multidisciplinary background team, lifelong learning skills and solid teamwork to provide satisfaction for the customers by giving high quality, efficient and one stop solution for regulatory consulting and clinical trial services. Qualtek bringing such number of advanced products to successfully enter the emerging markets in Asia by establishing a strong partnership with each customer, and has built its reputation by providing good quality and efficient regulatory solution. Qualtek currently has established its own company in Taiwan, China, Japan, Singapore, Malaysia, Philippines, Indonesia, Thailand, Vietnam, Hong Kong, US, etc. for providing local regulatory advice, product registration and license holding services.

Qualtek (Qualtech Group) 於2000年成立，目前在台灣、北京、大阪、新加坡、馬來西亞、菲律賓、印尼、泰國、越南、香港、美國等等均設有子公司，提供全球客戶全方位的醫療器材法規服務，為高品質高專業的法規及臨床研究顧問公司。 「穩健發展的工作環境、跨領域的專業團隊、誠實信賴的服務精神」是Qualtech Group成立多年來所秉持的經營理念，並以此信念強化團隊服務的效能，提升公司之企業形象與信譽；再搭配穩健經營的理念，走高品質的路線，不斷投入專業的訓練與擴展國際合作，以提升公司整體競爭力。由於Qualtech Group 有著不可取代的專業性與服務文化，為全球醫療器材公司在進入亞洲市場時，第一優先選擇我們為其合作夥伴！

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