Senior Post Market Surveillance Specialist

Senior Post Market Surveillance Specialist

Contract: 12 months

Start: ASAP

Location: Fully remote (UK)

PAYE: £153 per day

Umbrella: £207 per day

Have you got what it takes to succeed The following information should be read carefully by all candidates.

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 xwzovoh
• 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