Clinical Strategy & Regulatory Affairs Lead

BIOPTIMAL INTERNATIONAL PTE. LTD.; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading medical device company in Singapore is seeking a professional for clinical evaluation roles in invasive catheter and cardiology devices. Candidates should have a degree in medical or life sciences, at least 5 years of relevant experience, and strong regulatory knowledge. Responsibilities include ensuring compliance with MDR guidelines, handling technical documentation, and participating in clinical strategies. The ideal candidate is analytical, detail-oriented, and possesses excellent communication skills.

Qualifications

• 5 years professional experience in clinical evaluation of invasive catheter or cardiology medical devices.
• Working knowledge of regulatory requirements related to clinical evaluation.
• Fluency in English with strong technical writing skills.

Responsibilities

• Provide clinical expertise in evaluations according to MDR 2017/745 guidelines.
• Create and update technical documentation as per MDR requirements.
• Plan and implement clinical strategies adhering to applicable regulations.

Skills

Regulatory requirements knowledge

Research methodology

Technical writing

Data-driven analysis

Interpersonal skills

Education

Degree in medical or life science

PhD (added advantage)

Tools

Embase

Medline

PubMed

Job description

A leading medical device company in Singapore is seeking a professional for clinical evaluation roles in invasive catheter and cardiology devices. Candidates should have a degree in medical or life sciences, at least 5 years of relevant experience, and strong regulatory knowledge. Responsibilities include ensuring compliance with MDR guidelines, handling technical documentation, and participating in clinical strategies. The ideal candidate is analytical, detail-oriented, and possesses excellent communication skills.