Post Market Surveillance
1 week ago
Proclinical is proud to be partnered exclusively with our client, a an ASX-listed innovative, high-growth medical technology headquartered in Melbourne.
Our client designs, develops, and manufactures innovative Class III dermal regeneration solutions using a patented bioabsorbable polymer platform. Their life-saving products have transformed the treatment of burns, trauma, and complex wounds, improving outcomes for over 70,000 patients globally.
With a footprint in 46 countries, this organisation is scaling rapidly, backed by a strong pipeline of clinical programs and new indications. They offer a collaborative, forward-thinking culture where your work directly impacts patients' lives.
Role OverviewWe are seeking an experienced Post-Market Surveillance (PMS) Manager/ Senior Associate to lead the global PMS framework and ensure the ongoing safety and effectiveness of innovative medical devices.
This role is pivotal in complaint handling, data trending, safety signal detection, and global event reporting, while also mentoring a dedicated PMS team. You'll work cross-functionally with Quality, Regulatory, Medical, Commercial and R&D teams globally to maintain world-class standards of compliance and product performance.
Role Responsibilities- PMS System & Compliance – Own and maintain the PMS system, updating in line with evolving global regulations (EU MDR, FDA, TGA).
- Complaint Handling – Oversee global product complaint intake, investigations, and reportable events.
- Risk & Data Analysis – Lead trending meetings, literature reviews, and safety signal detection to support risk-benefit evaluations.
- Cross-Functional Collaboration – Partner with RA, QA, Medical, and R&D on PSURs, CERs, PMCF reports, and SSCPs.
- Leadership – Manage and mentor PMS staff, set clear objectives, and foster a high-performing, collaborative culture.
- Relevant tertiary qualifications, such as a Bachelor's degree in Biomedical Engineering, Nursing, or a Physician Medical Degree (MBBS / MD or equivalent).
- 8+ years' experience in medical device or pharma, with 2+ years' dedicated PMS/Vigilance experience.
- Strong working knowledge of EU MDR 2017/745, FDA MDR, ISO 13485, ISO 14971.
Proven strength in data interpretation and problem-solving, with a meticulous approach to detail.
Advanced technical writing and documentation abilities, producing clear, accurate, and compliant reports.
Confident communicator, able to build strong relationships and engage effectively with cross-functional teams, external stakeholders, and Key Opinion Leaders (KOLs).
Implantable / Class III medical device experience - highly regarded.
- Knowledge of the design, development, and clinical assessment of medical devices - highly regarded.
- Hands-on clinical awareness (such as supporting procedures in an operating room) - highly regarded.
If this opportunity aligns with your experience and career goals, please click 'Apply Now' to submit your application.
For a confidential discussion or to learn more about this role, please contact Pamela Phoumavong at or
About ProclinicalProclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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