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Clinical Evaluation Specialist

2 months ago

Singapore BIOPTIMAL INTERNATIONAL PTE. LTD. Full time
Job Description

Bioptimal International Pte. Ltd. is seeking a highly skilled Clinical Evaluation Specialist to join our team. As a key member of our Medical Affairs department, you will be responsible for providing clinical expertise in the evaluation of medical devices, ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities:
  • Clinical Evaluation: Provide clinical expertise in the evaluation of medical devices, including clinical trials, literature searches, and technical documentation.
  • Regulatory Compliance: Ensure compliance with regulatory requirements, including MDR 2017/745 and ISO 13485.
  • Technical Documentation: Create, review, and update technical documentation, including procedures, work instructions, and reports.
  • Market Research: Conduct market research and analysis on clinical trials and product outlook.
  • Internal Audits: Participate in internal audits and external certification audits to ensure compliance with industry standards.
  • Clinical Strategies: Develop and implement clinical strategies in accordance with applicable guidance and regulations.
  • Stakeholder Communication: Communicate with stakeholders, including Bioptimal's contracted manufacturer, to ensure clinical needs are met.
Requirements:
  • Education: Degree in medical or life science with at least 5 years of professional work experience in clinical evaluation.
  • Regulatory Knowledge: Working knowledge of regulatory requirements, including MDR 2017/745 and ISO 13485.
  • Research Methodology: Good research methodology, including clinical investigation design and biostatistics.
  • Technical Writing: Fluent in technical writing related to clinical evaluation and literature search and appraisal.
  • Communication Skills: Fluent in both verbal and written English, with good interpersonal and communication skills.