Medical Affairs Executive - D14 Geylang, Eunos, SG

Roles & Responsibilities

JOB DESCRIPTION

• Provide clinical expertise in clinical evaluation, and literature search and appraisal technical documentation according to MDR 2017 / 745 and MEDDEV guidelines.
• Provide clinical expertise in post-market clinical follow-up (PMCF) and post-market surveillance (PMS) technical documentation including the creation and update of the Summary of Safety and Clinical Performance (SSCP) according to MDR 2017 / 745 and MDCG guidelines.
• Provide safety and clinical assessment of complaints and adverse events including technical write-up of the manufacturer’s incident report (MIR).
• Create, review and update procedures, work instructions, protocols and reports related to clinical evaluation, literature search and appraisal, post-market clinical follow-up (PMCF), post-market surveillance (PMS) and Summary of Safety and Clinical Performance (SSCP) according to current standards and guidance, and periodic schedule.
• Participate in the risk management team and provide safety and clinical assessment in the risk management file (RMF) on identified risks from different data sources during post-production processes that is in accordance with the requirements of ISO 14971.
• Provide support in the MDR documentation, application, submission and review as and when needed by the superior.
• Provide support in the creation, update and maintenance of the technical files according to MDR 2017 / 745 requirements.
• Perform market research and analysis on clinical trials and product outlook from different online sources.
• Provide support on the internal audits and external certification audits in compliance with ISO 13485, other applicable standards and regulations.
• Plan, develop and implement clinical strategies in accordance with applicable guidance, standards and regulations.
• Interface with Bioptimal’s contracted manufacturer on the clinical needs of the company and the strategies to obtain compliance to applicable guidance, standards and regulations.
• Act as Singapore representative in communicating the clinical needs to different stakeholders and obtaining approval on clinical evaluations.
• Take lead in the creation, update, execution, follow-up and compiling of clinical surveys according to procedure.

REQUIREMENTS

Tell employers what skills you have

Market Research

Outlook

Technical Documentation

Written English

Technical Writing

Information Management

Investigation

Clinical Trials

Medical Affairs

Regulatory Requirements

Biostatistics