에드워즈라이프사이언시스코리아 · Spec, Regulatory Affairs

Key Responsibilities:
• Prepare and complete product registration tasks covering the new product registration, the registration amendment, and the renewal registration. Ensure product tests/samples meet safety and performance requirements of regulatory agencies in collaboration with lab technicians
• Prepare clinical trial and evaluation report applications according to government regulations, hospital ethics committee needs, and company requirements for submission
• Create local language labels and Instruction For Use in compliance of country regulations before passing them to Supply Chain
• Liaise with regulatory agencies to facilitate and expedite review and approval of company products, registrations, submissions, reformulations etc
• Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements
• Serve as regulatory liaison throughout product lifecycle. Participates in regulatory strategy and operating plans
• Handle product recall reporting to regulatory agencies, for products exhibiting non-compliance
• Review marketing advertisements to ensure compliance to regulations and submit to FDA for approval
• Other incidental duties; Serve as regulatory representative to sales & marketing team, clinical team and regulatory agencies


Education and Experience:
Bachelor’s Degree or equivalent in related field, 3 Years years experience previous related experience Required or
Bachelor’s Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry) Experience in preparing domestic and international product submissions Preferred
Other: Coursework, seminars, and/or other formal government and/or trade association training Required


Additional Skills:
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, organizational, analytical and critical thinking skills
• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Solid knowledge and understanding of global regulatory requirements for new products or product changes.
• Solid knowledge of new product development systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Work is performed independently on complex projects and/or lines of work and reviewed for accuracy and soundness
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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