Senior Regulatory Affairs Professional for Medical Device Product Registration

21 hours ago


Singapore CorDx Full time

**CorDx Opportunity:** We are seeking a seasoned Regulatory Affairs Executive to lead our medical device product registration efforts.

Job Description:

We are looking for a highly skilled and experienced Regulatory Affairs Professional to join our team at CorDx. As a key member of our regulatory affairs team, you will be responsible for managing the product registration process for our medical devices in various regions.

Main Responsibilities:
  • Product Registration: Prepare and submit registration dossiers, design performance evaluation studies, and manage execution and communication with clinical research organizations (CROs).
  • Laws and Regulations: Serve as the subject matter expert on medical devices laws and regulations for product registration in our target regions.
  • Regulatory Agency Interface: Communicate with regulatory agencies, track progress, and resolve issues raised during review processes.
  • Product Testing and Verification: Participate in product testing, clinical verification, data collection, and tracking.
  • Scientific Projects: Submit scientific special projects on behalf of the company to regulatory agencies.
  • Cross-Functional Collaboration: Establish working relationships with key opinion leaders and regulatory bodies, and collaborate with cross-functional teams to achieve project goals.
Requirements:

To succeed in this role, you must have:

  • A bachelor's degree in Life Sciences, Pharmacy, or a related field.
  • Familiarity with ISO 13485 quality management systems and solid medical device quality management qualifications.
  • Expertise in medical device product registration laws and regulations, including experience drafting registration dossiers.
  • Complete registration experience with Class B, C, and D medical devices.
  • Familiarity with in vitro diagnostic products, such as lateral flow immunoassay, PCR, and immunoassay.
  • Knowledge of IVD product development and commercialization life cycles.
  • Strong project management skills, including planning, execution, and timely communication.
  • Excellent presentation skills and the ability to handle stress and tight schedules.

We offer a competitive salary range of $120,000 - $150,000 per annum, depending on experience, plus benefits and opportunities for professional growth.



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