Regulatory Affairs Specialist

1 day ago

Singapore AITBIOTECH PTE. LTD. Full time

**Regulatory Affairs Specialist
**Responsibilities**:

- Responsible for regulatory activities
- 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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