Senior Post Market Surveillance Specialist

SRG; United Kingdom; Remote; GBP 45,000 - 65,000; Full time

Job summary

A leading company in medical products is looking for a Senior Post Market Surveillance Specialist. This remote role involves maintaining product quality standards and complying with all regulatory requirements in chronic condition management. Responsibilities include executing surveillance processes, facilitating reports, and ensuring compliance and safety within the organization.

Qualifications

• Minimum of 5 years experience in a quality role in medical device or life sciences.
• Practical experience in global quality standards and regulations.
• Experience in post-market surveillance activities.

Responsibilities

• Execute Post Market Surveillance related processes.
• Participate in design control activities and provide risk assessments.
• Support investigations arising from CAPA, complaints and audits.

Skills

Excellent written and verbal communication

Ability to navigate government regulations and standards

Advanced MS Excel skills

Strong proficiency in Minitab

Education

B.S. in a scientific/technical discipline

Tools

Track wise

QMS

Job description

Senior Post Market Surveillance Specialist

Senior Post Market Surveillance Specialist

Get AI-powered advice on this job and more exclusive features.

• 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

Sign in to set job alerts for “Market Specialist” roles.

London, England, United Kingdom 3 weeks ago

Leeds, England, United Kingdom 3 weeks ago

London, England, United Kingdom 1 week ago

Bristol, England, United Kingdom 3 weeks ago

Greater Manchester, England, United Kingdom 3 weeks ago

Southampton, England, United Kingdom 3 weeks ago

Birmingham, England, United Kingdom 3 weeks ago

Sheffield, England, United Kingdom 3 weeks ago

Nottingham, England, United Kingdom 3 weeks ago

Newcastle Upon Tyne, England, United Kingdom 3 weeks ago

London, England, United Kingdom 2 weeks ago

NOW HIRING: Sales Specialist | SaaS/Post Trade Banking

London, England, United Kingdom 1 week ago

Barnet, England, United Kingdom 2 weeks ago

Romford, England, United Kingdom 2 weeks ago

London, England, United Kingdom 10 hours ago

Islington, England, United Kingdom 3 days ago

Bexley, England, United Kingdom 3 weeks ago

Regional Sales Manager – New to Market Electric Vehicle Brand

London, England, United Kingdom 1 week ago

Senior Go-to-Market Operations Specialist

London, England, United Kingdom 1 month ago

London, England, United Kingdom 2 weeks ago

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