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
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