Senior Post Market Surveillance Specialist

SRG; United Kingdom; Remote; GBP 45,000 - 60,000; Full time

Job summary

A leading company in medical technologies seeks a Senior Post Market Surveillance Specialist to ensure compliance with quality standards in product surveillance. You will lead surveillance processes, collaborate with teams on product safety, and support continuous quality improvement. Ideal candidates should have significant experience in the medical sector and strong analytical skills.

Qualifications

• 5+ years experience in a quality role in medical devices.
• Experience in product development lifecycle and regulations.
• Practical expertise in post-market surveillance activities.

Responsibilities

• Execute Post Market Surveillance processes and maintain compliance.
• Facilitate Post Market Surveillance reports and product monitoring.
• Support investigations and continuous improvement efforts.

Skills

Communication

Risk Management

Regulatory Compliance

Data Analysis

Quality Assurance

Education

B.S. in scientific/technical discipline

Tools

TrackWise

QMS

MS Excel

Minitab

Job description

Senior Post Market Surveillance Specialist

Senior Post Market Surveillance Specialist

• Job Title: Senior Post Market Surveillance Specialist
• Contract: until 31/1/26
• Location: Remote

SRG are partnered with a global medical products and technologies company. Our client is focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care.

Our client is seeking a Senior Post Market Surveillance Specialist to join their team.

This position will have the objective of maintaining high quality standards for the product manufacturing and compliance with all applicable regulatory requirements.

The Senior Post Market Quality Engineer is responsible and accountable for quality product surveillance deliverables required within the post market compliance & surveillance processes across Infusion Care business unit.

Key Responsibilities:

• Execute the Post Market Surveillance related processes
• Establishes and maintains Post Market Surveillance Plans and maintains update schedule.
• Facilitates and compiles Post Market Surveillance (including PSUR) reports.
• Maintenance of product malfunction codes across Infusion Care business units.
• Participates in complaint escalation reviews.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Timely and accurate presentation of complaint analysis to all stakeholders.
• Support quality engineering activities for all post market product surveillance including collection, analysis, and evaluation of product safety and performance data, and detection of trends in data that may warrant further action
• Execute and maintain procedures and processes to address post-market surveillance activities such as product investigations, periodic and ad hoc risk reviews, and product monitoring (trending and tracking) across all product franchises.
• Partnering with team members (and cross-functional teams) to ensure the development and execution of streamlined robust solutions to post-market quality processes are effectively implemented.

Design and Development:

• Develop understanding of the current risk profile for all products including reportable product harms and malfunctions
• Provide quality and compliance input to project teams for project decisions and deliverables, especially those related to risk.
• Participate in design control activities and provide input into identifying failure modes and risk assessment for new and existing products while providing expertise in product complaint history and occurrence levels

Quality Management System:

• Adhere to all requirements of the Quality Management System.
• Support investigations arising from CAPA, complaints, Health Hazard Evaluations (HHE), Internal audits, third party inspections, and other business processes by applying typical quality/problem solving tools such as fishbone/cause & effect, Pareto, process mapping, etc.
• Continuously support Quality Master Systems Data update for Product Lifecycle, including but not limited to, New Product Introduction, Product Obsolescence, Heightened Product Surveillance and Manufacturing Site updates.

Management review:

• Provide Post Market Surveillance Quality Input to Management Review slide decks as required.

Audit:

• Support internal audits as required and act as an SME for the BU represented.
• Support external audits as required and act as an SME for the BU represented.

Other responsibilities:

• Overall responsibility for ensuring technical rigor and compliance to applicable procedures during risk management, complaint, CAPA, and design related processes.
• Support R&D, Operations, Marketing, Clinical Affairs, Regulatory, Post Market Surveillance, external customers and equipment suppliers.
• The job holder will demonstrate the highest Quality standards, be able to impart knowledge and increase best practice across site/s and will embrace/drive core mission, values and priorities
• Support continuous improvement of post market surveillance procedures, processes, and tools.
• To lead/manage microbiology laboratory related non-conformances, CAPA’s, planned deviations, change controls, OOS’s as required, ensuring corrective actions are fully implemented to address root causes etc.
• Perform other activities as and when required to support laboratory operations.

Skills & Experience:

• Demonstrate company values, work with integrity, and be a supportive team member.
• Excellent written and verbal communication skills
• Ability to navigate government regulations and standards, including Regulation (EU) 2017/745, 21 CFR 820, Part 203, ISO 13485 and ISO 14971.
• Experience with track wise, QMS
• Safety reporting
• Advanced MS Excel skills, including the ability to independently create and utilize pivot tables and charts, formulas, V-lookups, and other advanced data manipulation
• Strong proficiency in Minitab
• Ability to maintain composure and focus while managing multiple priorities, changing workloads, and meeting critical deadlines

Qualifications/Education:

• Minimum of B.S., or equivalent experience, in a scientific/technical discipline is required.
• At least 5 years experience in quality role in a medical device or life sciences technology driven company.
• Practical experience and global mastery in global quality standards and regulations governing medical products.
• Experience with various phases of the product development lifecycle including concept, design, implementation, verification, and validation activities necessary for product commercialization
• Experience in product and process risk management.
• Experience in post-market surveillance activities (tracking and trending, investigations)

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Temporary

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at SRG by 2x

Get notified about new Market Specialist jobs in United Kingdom.

Islington, England, United Kingdom 2 weeks ago

Belfast, Northern Ireland, United Kingdom 3 weeks ago

London, England, United Kingdom 1 month ago

Sales and Business Development Specialist

Farnborough, England, United Kingdom 1 week ago

Bromley, England, United Kingdom 3 weeks ago

Glasgow, Scotland, United Kingdom 3 weeks ago

Senior Post Market Surveillance Specialist

Deeside, Wales, United Kingdom 2 weeks ago

Greater London, England, United Kingdom 3 weeks ago

Armagh, Northern Ireland, United Kingdom 3 weeks ago

Sales Specialist | J&J MedTech | Neurovascular | Hull, Leeds, Sheffield, Nottingham

Leeds, England, United Kingdom 1 week ago

Mid-Market Account Executive (UK Market)

London, England, United Kingdom 1 week ago

London, England, United Kingdom 6 months ago

Cornwall, England, United Kingdom 1 week ago

Marketing and Sales Enablement Specialist

London, England, United Kingdom 4 days ago

Liverpool, England, United Kingdom 1 month ago

Southampton, England, United Kingdom 1 month ago

UK Sales Manager - Leading SaaS for Legal (SME Market). Remote

Little London, England, United Kingdom 3 weeks ago

Sales Specialist | J&J MedTech | Neurovascular | Hull, Leeds, Sheffield, Nottingham

Nottingham, England, United Kingdom 1 week ago

Sheffield, England, United Kingdom 6 days ago

Aston, England, United Kingdom 2 weeks ago

Regional Sales Manager, Mid-Market (Remote, GBR)

Reading, England, United Kingdom 1 week ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.