Regulatory Affairs Professional

3 days ago


Singapore AITBIOTECH PTE. LTD. Full time
Job Description:

AITBIOTECH PTE. LTD. is a growing biotech company focusing on molecular diagnostics and automated diagnostics solutions.

We are seeking a highly skilled Regulatory Affairs Specialist to support the sales of our products and services.

The successful candidate will be responsible for regulatory activities, liaising with regulatory authorities, and collaborating with cross-functional departments to ensure timely implementation of document change requests.

Key Responsibilities:

  • Responsible for regulatory activities and ensuring compliance with relevant regulations.
  • Liaise with regulatory authorities and follow-up on application status.
  • Collaborate with cross-functional departments to ensure timely implementation of document change requests.
  • Develop and establish policies and standards that convey best practices in the company.
  • Work closely with lab and sales teams to drive quality and business efficiencies and processes.
  • Ensure products are registered in time for market launch.
  • Maintain quality management systems and be 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 ISO 13485, GDPMDs, and any other standards as appropriate.
  • Support quality management audits (internal & external) 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, fostering a culture of continuous improvements to improve process control and quality yields.
  • Keep up-to-date with changes in regulatory legislation and guidelines.
  • Provide 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.
  • Provide 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 managing regulatory of life science products or devices.
  • Understanding in HSA requirements and product approval such as ISO 13485, 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.

Salary: Estimated SGD $80,000 - $120,000 per annum, depending on qualifications and experience.



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