Total 1 job vacancies by Aitbiotech Pte. Ltd.

AITbiotech Pte Ltd (http://www.aitbiotech.com),a growing biotech company which focuses on molecular diagnostics and automated diagnostics solution, is looking to hire a Regulatory Affairs Specialist to support the sales of its products and services.

Regulatory Affairs Specialist

Job Responsibilities:

• Responsible for regulatory activities
• Liaise with regulatory authorities and follow-up on application status
• Collaborates with cross-functional departments to ensure timely implementation of document change requests
• Develop and establish policies and standards that convey the best practices in the company
• Work closely with lab and sales team to help drive quality and business efficiencies and processes
• Ensure products are registered in time for market launch
• Maintain quality management system and responsible for all aspects of quality procedures, standards and specifications with approval from Quality Management Representative (QMR).
• Manage document control process for Quality Management Systems in compliance with ISO13485, GDPMDS and any other standards as appropriate
• Support quality management audits (internal & external) in order to verify that regulatory and quality requirements have been met and proper closure of non-compliance activities
• Take leadership role in developing and implementing advanced quality principles, foster a culture of continuous improvements to improve process control and quality yields
• Keep up-to-date with changes in regulatory legislation and guidelines
• Provides guidance and advice on approved procedures, standardization and requirements associated with the document management system.
• Provide expert regulatory input to in-licensing evaluations and due diligence activities
• Provides training to new staff on document management system and document management processes and procedures
• Management of nonconformance, customer complaints handling and supplier auditing, etc
• Ability to manage multiple simultaneous activities in a rapidly changing environment

Requirements:

• Bachelor’s degree or Diploma holder, preferably in Biomedical Sciences, Biology, Biochemistry, Pharmacy or Pharmacology
• Min 3 years of working experience in manage regulatory of life science products or devices.
• Understanding in HSA requirements and product approval such as ISO13485, CE-IVD is a must.
• Fluent English; excellent written and verbal communication skills.
• Proficient in Microsoft Office
• Good interpersonal skills to frequently work with colleagues and team members, and advise others on compliance and regulatory matters
• Excellent analytical skills Attention to detail
• Pro-active and problem-solving attitude
• Highly autonomous, yet with a profound team spirit