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.
