Regulatory Affairs Specialist

1 month ago


Singapur, Singapore CorDx Full time
Job Title: Regulatory Affairs Executive

CorDx is seeking a highly skilled Regulatory Affairs Executive to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with medical device regulations and laws in our regions of interest.

Key Responsibilities:
  1. Product Registration: Prepare registration dossiers, design performance evaluation studies, and manage execution and communication with CROs.
  2. Regulatory Expertise: Be the subject matter expert on medical devices laws and regulations for product registration in our regions of interest.
  3. Regulatory Interface: Communicate with regulatory agencies, track progress, and resolve problems raised by reviewers.
  4. Product Testing: Involve in product testing, clinical verification, data collection, and tracking.
  5. Scientific Projects: Submit scientific special projects to agencies on behalf of the company.
  6. Collaboration: Establish collaborative relationships with key opinion leaders and regulatory bodies.
  7. Team Collaboration: Collaborate with cross-functional teams to meet project goals and organizational objectives.
Requirements:
  1. Education: Bachelor's degree in Life Sciences, Pharmacy, or a related field.
  2. Quality Management: Familiar with ISO13485 quality management system and solid medical device quality management qualifications.
  3. Regulatory Expertise: Expert in medical device product registration laws and regulations, able to independently draft registration dossiers.
  4. Registration Experience: Complete registration experience of Class B, C, and D medical devices.
  5. IVD Products: Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, and Immunoassay.
  6. Project Management: Systematically project management, good planning, execution, and timely communication.
  7. Soft Skills: Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
  8. Responsibility: Meticulous and strong sense of responsibility; able to handle stress and tight schedule.


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