Medical Affairs Executive

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

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

• Degree in medical or in life science with at least 5 years professional work experience in invasive catheter or cardiology related medical devices’ clinical evaluation, with PhD is an added advantage.
• Working knowledge on regulatory requirements relating to clinical evaluation is a must, with MDR 2017/745 background is an added advantage.
• Preferably with good research methodology (including clinical investigation design and biostatistics).
• Must be scientific and data-driven with good information management (experience with relevant databases such as Embase, Medline, PubMed, etc.)
• Fluent and experienced in technical writing related to clinical evaluation and literature search and appraisal.
• Fluent in both verbal and written English.
• With high level of integrity and able to work on tight deadlines and deliver results as per schedules.
• Self-starter, independent, analytical thinker and able to recommend sound, logical advice to management in accordance with applicable regulations and guidance.
• With good interpersonal and communication skills, positive outlook and able to get along with peers.