Post Market Surveillance Manager

TN United Kingdom; Oxford; On-site; GBP 40,000 - 80,000; Full time

Job summary

An innovative firm is seeking a Post Market Surveillance Manager to oversee compliance activities in the diagnostics sector. This role involves coordinating post-market tasks, ensuring adherence to quality management systems, and collaborating across departments. With a focus on real-time analysis and cutting-edge technologies, you will play a crucial role in maintaining product performance and regulatory compliance. Join a dynamic team in a stimulating environment that values your contributions and offers opportunities for professional growth. Make a meaningful impact in the field of diagnostics and apply today!

Benefits

Private Healthcare

Generous Pension Contributions

Stimulating Working Environment

Qualifications

• 3+ years in regulatory affairs within diagnostics.
• Solid understanding of IVD device regulations and ISO 13485.

Responsibilities

• Coordinate post-market surveillance tasks and ensure compliance.
• Collaborate with teams to gather and analyze PMS data.

Skills

Regulatory Affairs

Post Market Surveillance

Communication Skills

Analytical Skills

Problem-Solving

Job description

Post Market Surveillance Manager, Oxford

Client: Oxford Nanopore Technologies

Location: Oxford, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 2367d62c5843

Job Views: 12

Posted: 02.05.2025

Expiry Date: 16.06.2025

Job Description:

Oxford Nanopore Technologies, headquartered at the Oxford Science Park outside Oxford, UK, with satellite offices and a global presence across the US, APAC, and Europe, employs experts in nanopore science, molecular biology, informatics, engineering, electronics, manufacturing, and commercialization. Led by CEO Dr. Gordon Sanghera, the company is known for delivering disruptive sequencing technologies.

The company's sequencing platform offers real-time analysis in scalable formats from pocket to population scale, capable of analyzing native DNA or RNA and sequencing fragments of any length to achieve various read lengths. Our mission is to enable the analysis of any living thing, by anyone, anywhere.

Role Overview:

Reporting to the Regulatory Affairs Manager, this role involves coordinating all post-market activities to ensure compliance with the OND Quality Management System (QMS) and regulatory reporting timelines. The role includes providing regular updates to the Regulatory Affairs Manager and collaborating across departments to fulfill post-market obligations.

Key Responsibilities:

• Organize and coordinate post-market surveillance tasks according to OND QMS policies, procedures, and international regulations.
• Ensure compliance with individual product Post Market Surveillance plans.
• Collaborate with technical services and external partners to gather, triage, escalate, and complete PMS information.
• Coordinate cross-functional investigations, including data gathering, analysis, and reporting.
• Establish and maintain PMS information sources for customer feedback and product performance monitoring.
• Provide timely PMS data for vigilance reporting.
• Educate staff on PMS requirements.
• Maintain and improve PMS procedures in collaboration with QA and Regulatory teams.
• Create and update PMS reports and contribute to management reviews.

Qualifications and Skills:

Candidates should have at least 3 years of experience in regulatory affairs within the diagnostics industry, with a solid understanding of IVD device regulations, post-market surveillance, 21CFR, IVDR, and ISO 13485. Key skills include strong communication, excellent writing, teamwork, analytical and problem-solving abilities, persuasion, decision-making, and escalation when necessary.

Benefits:

We offer an attractive salary, bonus, generous pension contributions, private healthcare, and a stimulating working environment surrounded by landscaped grounds, water features, and a lake. Join us to make a meaningful impact and apply today!