Senior Post Market Surveillance Specialist
Contract: 12 months
Start: ASAP
Location: Fully remote (UK)
PAYE: £153 per day
Umbrella: £207 per day
The Role
We’re looking for an experienced Senior Post Market Surveillance Specialist to support global post‑market surveillance activities within a regulated medical device environment. This is a hands‑on contract role focused on executing post‑market surveillance plans, analysing complex datasets, and ensuring ongoing compliance with global regulatory requirements.
You’ll play a key role in maintaining high standards of product quality and patient safety, working closely with cross‑functional teams across Quality, Regulatory, R&D, Operations and Clinical.
Key Responsibilities
Post Market Surveillance
* Execute post‑market surveillance processes in line with regulatory and internal requirements
* Establish, maintain and update Post Market Surveillance Plans
* Compile and facilitate Post‑Market Surveillance and PSUR reports
* Analyse complaint and product performance data, identifying trends and escalation risks
* Maintain product malfunction codes and support complaint escalation reviews
* Present timely and accurate complaint and surveillance insights to stakeholders
* Support investigations, risk reviews and trending activities across product portfolios
Risk, Design & Development
* Maintain a strong understanding of product risk profiles, including reportable harms and malfunctions
* Provide quality and compliance input into risk management and design control activities
* Support failure mode identification and risk assessments for new and existing products
Quality Management & Compliance
* Operate in full compliance with the Quality Management System
* Support CAPA, complaint investigations, health hazard evaluations, and audit activities
* Act as an SME during internal and external audits
* Contribute post‑market surveillance input to management review materials
* Drive continuous improvement of post‑market surveillance processes, tools and reporting
Skills & Experience
Essential
* Strong background in Post Market Surveillance within medical devices or life sciences
* In‑depth knowledge of global regulations and standards including MDR (EU 2017/745), 21 CFR 820, ISO 13485 and ISO 14971
* Excellent data analysis capability with advanced MS Excel (pivot tables, VLOOKUPs, formulas, charts)
* Strong proficiency in Minitab
* Excellent written and verbal communication skills
* Ability to manage multiple priorities in a fast‑paced, regulated environment
Desirable
* Six Sigma Green or Black Belt
* Statistical Analysis certification
Qualifications
* BSc (or equivalent experience) in a scientific or technical discipline
* Minimum 5 years’ experience in a quality engineering or post‑market surveillance role
* Experience across the product lifecycle, including risk management and post‑market activities