Clinical Evaluation Specialist

2 days ago


Singapore BIOPTIMAL INTERNATIONAL PTE. LTD. Full time
Job Title: Medical Affairs Executive

About the Role:

We are seeking a highly skilled Medical Affairs Executive to join our team at Bioptimal International Pte. Ltd. The successful candidate will be responsible for providing clinical expertise in clinical evaluation, literature search and appraisal, post-market clinical follow-up, and post-market surveillance.

Key Responsibilities:

  • Provide clinical expertise in clinical evaluation, literature search and appraisal, and post-market clinical follow-up and surveillance.
  • Develop and implement clinical strategies in accordance with applicable guidance and regulations.
  • Interface with our contracted manufacturer on clinical needs and strategies to obtain compliance.
  • Act as Singapore representative in communicating clinical needs to stakeholders and obtaining approval.
  • Lead the creation, update, execution, and follow-up of clinical surveys.

Requirements:

  • Degree in medical or life science with at least 5 years of professional work experience in clinical evaluation.
  • Working knowledge of regulatory requirements relating to clinical evaluation, with MDR 2017/745 background an advantage.
  • Good research methodology, including clinical investigation design and biostatistics.
  • Scientific and data-driven with good information management skills.
  • Fluent in technical writing related to clinical evaluation and literature search and appraisal.
  • Fluent in both verbal and written English.

What We Offer:

As a Medical Affairs Executive at Bioptimal International Pte. Ltd., you will have the opportunity to work with a dynamic team and contribute to the development of our medical devices. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

How to Apply:

If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information].



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