Job Description

Post Market Surveillance (Manager / Senior)

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Role Overview

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We 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 cutting-edge medical devices. This role is pivotal in complaint handling, data trending, safety signal detection, and global event reporting, while mentoring a 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.

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Role Responsibilities

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- PMS System & Compliance – Own and maintain the PMS system, updating in line with evolving global regulations (EU MDR, FDA, TGA) and reporting requirements such as Periodic Safety Update Reports (PSURs).
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- Complaint Handling – Oversee global product complaint intake, investigations, and adverse event and recall reporting and database reviews.
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- Risk & Data Analysis – Lead trending meetings, literature reviews, and safety coding of clinical signals (MedDRA & IMDRF) to support risk-benefit evaluations.
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- Cross-Functional Collaboration – Partner with RA, QA, Commercial, Medical, and R&D; on PSURs, CERs, PMCF reports, and SSCPs.
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- Leadership – Mentor PMS staff, set clear objectives, and foster a high-performing, collaborative culture.
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Skills and Experience

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- Relevant tertiary qualifications, such as a Bachelor's degree in Biomedical Engineering, Nursing,



or a Physician Medical Degree (MBBS/ MD or equivalent).
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- 8+ years' experience in medical device or pharma, with 2+ years' dedicated PMS/Vigilance experience.
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- Strong working knowledge of EU MDR 2017/745, FDA MDR, ISO 13485, ISO 14971.
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- Proven strength in data interpretation and problem-solving, with a meticulous approach to detail.
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- Advanced technical writing and documentation abilities, producing clear, accurate, and compliant reports.
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- Confident communicator, able to build strong relationships and engage effectively with cross-functional teams, external stakeholders, and Key Opinion Leaders (KOLs).
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- Implantable / Class III medical device experience - highly regarded.
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- Knowledge of the design, development, and clinical assessment of medical devices - highly regarded.
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- Hands-on clinical awareness (such as supporting procedures in an operating room) - highly regarded.
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How to Apply

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If this opportunity aligns with your experience and career goals, please click "Apply Now" to submit your application.

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For a confidential discussion or to learn more about this role, please contact Pamela Phoumavong at [email protected] or 0493 093 532.

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About Proclinical

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Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

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Proclinical Staffing is an equal opportunity employer.

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📌 Post Market Surveillance (Manager / Senior) (Victoria)
🏢 Proclinical Staffing
📍 Victoria