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A leading medical technology firm in Puchong, Malaysia, seeks a Clinical Advisor to drive the clinical strategy and oversee evidence generation for its wound care portfolio. You will manage clinical trials, train healthcare professionals, and ensure regulatory compliance. The ideal candidate holds a relevant degree with at least 10 years of experience in wound care and expertise in clinical studies. Strong communication skills and the ability to engage key opinion leaders are essential. Join us to make a significant impact in the field of medical technology.
The Clinical Advisor is responsible for driving the company’s clinical strategy, evidence generation, and post-market clinical activities to support regulatory compliance, product adoption, and commercial growth of the medical technology portfolio. This role leads clinical studies, manages relationships with healthcare professionals, KOLs, supports cross-functional teams with clinical insights, and ensures safe, effective, and compliant clinical use of the company’s products.
Develop and execute robust clinical evidence plans for chronic wounds (DFUs, VLUs, pressure injuries), surgical wounds, and burns.
Identify clinical and evidence gaps to support regulatory submissions, reimbursement strategies, and market acceleration.
Guide development of clinical claims, value propositions, and health economic evidence (e.g., cost savings, reduction in healing time).
Design, initiate, and manage clinical trials, PMCF programs, registries, and observational studies.
Lead site selection, ethics/IRB submissions, contracting, start-up activities, and ongoing site monitoring.
Ensure all clinical activities comply with ISO 14155, GCP, EU MDR, and applicable local regulatory requirements.
Train clinicians, wound care specialists, and sales teams on the safe and effective use of company technologies.
Develop clinical education materials including protocols, user manuals, treatment pathways, and training modules.
Provide advanced clinical support across hospitals, outpatient clinics, home healthcare, and long-term care facilities.
Lead product safety event reporting and follow-up, including adverse event assessment and escalation.
Develop PMCF plans, support CER inputs, and conduct vigilance activities as required.
Monitor product performance trends such as infection rates, dressing performance, exudate leakage, and device malfunctions.
Build and maintain strong relationships with wound care nurses, tissue viability nurses, podiatrists, dermatologists, and key opinion leaders (KOLs).
Organize advisory boards, clinical roundtables, evaluations, and user feedback forums.
Support scientific publications, clinical case studies, and conference activities (e.g., EWMA, WoundCon, SAWC).
Provide clinical expertise to product development teams for design improvements (adhesion, absorbency, wear time, ergonomics).
Support Marketing with clinical messaging, claims validation, scientific content, and thought leadership materials.
Collaborate with Regulatory, Quality, and Commercial teams to ensure clinical alignment across projects.
Translate clinical workflow requirements into product specifications and development priorities.
Identify unmet needs in chronic wound management, driving innovation and new clinical pathways.
Participate in formative and summative usability testing to validate product design and user experience.
Degree in Medicine, Nursing, Life Sciences, Biomedical Engineering, or a related field.
Advanced practice wound care certification is strongly preferred (e.g., WOCN, WCN, TVN, CNS with wound care focus).
Minimum 10 years of experience in wound care—clinical, tissue viability, R&D, clinical affairs, or related functions.
Proven experience designing, managing, or supporting wound care clinical studies.
Strong understanding of both hospital-based and community wound care workflows and clinical practices.
Strong understanding of clinical research methodologies and regulatory frameworks.
Excellent communication and presentation skills with the ability to train and influence clinical stakeholders.
Strong analytical, problem-solving, and documentation abilities.
Ability to work cross-functionally and manage multiple clinical programs simultaneously.
High degree of professionalism, independence, and strategic thinking.