Regulatory Affairs

6 days ago


Petaling Jaya, Malaysia Agensi Pekerjaan Recruit Express Sdn Bhd Full time

Job Description Review, prepare, compile and submit all documentations required for medical device submissions, license renewal, new device registrations and change notifications with relevant regulatory agencies Manages and implements internal regulatory tracking/ control systems Keep abreast of regulatory requirement and changes Liaise with regulatory agencies on defined matters Manages post market surveillance activities work closely with Global RA partners to obtain registration documents Participate in monthly regulatory meeting with Global RA partners Establish close interaction with local business team via monthly regulatory meeting Anticipate regulatory obstacles and emerging issues throughout the device registration cycle. Provide solution or escalate if needed to overcome the issues Involve in GDPMD internal and external audit annually Evaluate new requirements and provide business impact if any Reviews and approves local labelling to endure proper process is in place locally adjust or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area Job Requirement Bachelor degree in Science or related discipline Good knowledge in Malaysia Medical Device Regulation Preferred 3-5 years of Regulatory Affairs experience in the Medical Device industry Experience in cross functional working in a matrix organization Must be willing o travel for submissions purpose
Established in 1996, we have grown to become a leading recruitment consultancy firm with 14 offices in Singapore and footprints in Hong Kong, Kuala Lumpur and Taipei. 2017 is a significant year for us as we get listed on the Singapore Stock Exchange. Our Mission: We Help People Find Good Jobs and Our Clinets to Succeed in Business. Our Vision: To Be The Leading and Most Admired Recruitment and Staffing Consulting Firm in Singapore and Asia Pacific.
Bachelor's or Equivalent



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