Regulatory Compliance Specialist

1 day ago

Singapore beBeeRegulatory Full time $2,000 - $4,800

Job Title: Regulatory Compliance Specialist

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We are seeking a skilled and detail-oriented individual to join our team as a Regulatory Compliance Specialist. This role will be responsible for ensuring that our products meet all relevant regulatory requirements, from initial product design through to market launch.

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Main Job Scope:

  • Manage the development and implementation of Quality Management Systems (QMS) to ensure compliance with regulatory standards such as ISO 13485.
  • Determine the regulatory pathway for product registration with relevant authorities, including FDA, CE Mark, NMPA, and HSA.
  • Create and manage documentation required for regulatory clearance, including technical documents, user manuals, and labeling.
  • Work closely with cross-functional teams to ensure that product designs meet regulatory requirements.
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Requirements:

  • Bachelor's degree in Biomedical Engineering, Electrical and Electronic Engineering, Mechanical Engineering, or a related field.
  • Prior experience in quality management and regulatory affairs is an advantage.
  • Strong organizational, analytical, and communication skills.
  • Able to work independently and as part of a team.
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Benefits:

  • Competitive salary range: S$2,000 - S$4,800 per month.
  • Subsidized medical insurance and annual leave.
  • Opportunity to work on algorithms designed for patients and doctors.
  • Chance to interact with regulatory experts and other professionals.
  • Flexible work arrangement.
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Application Process:

Please apply through this portal or email your resume to Human Resources.

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