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Regulatory Affairs Specialist (Medical Devices)

Keywords / Skills : Regulatory Affairs Specialist (Medical Devices)

3 - 3 years
Posted: 2019-01-10

Other Roles
Posted On
10th Jan 2019
Job Ref code
Job Description
Global renowned medical devices company with more than 100 offices worldwide Great company culture with good benefits Located in the west of Singapore A global renowned medical devices MNC is looking for highly motivated, resilient and meticulous regulatory affairs specialist to join their team. You will be responsible for submissions for new products, variations and renewals. You will be interacting frequently with internal and external stakeholders to develop regulatory strategies and to provide timely updates. Responsibilities Compile dossiers for preparation of submissions and renewals in a timely manner for Singapore and ASEAN countries. Develops and provides regulatory advice for developing products Work closely with various teams (marketing/ supply chain/ manufacturing) to obtain timely regulatory approvals and stock management Monitor changes in the global regulatory framework in order to develop and implement regulatory strategies to facilitate on-going registration activities. Develop standard operating procedures, regulatory documents according to ASEAN, EU, US and other international markets regulations. Liaise with relevant regulatory bodies to maintain regulatory compliance of manufacturers in Europe and Singapore. Requirements Degree holder with minimum of 3 years’ regional regulatory experience in medical devices’ space Familiar with European Medical Device Directive, FDA 510(k) and ASEAN markets’ regulations Excellent verbal and written communication skills to facilitate clear and precise communications between different stakeholders Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).

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