This is an IT support group | Regulatory Affairs Specialist
18 hours ago
AITbiotech Pte Ltd, 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.
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
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