Post Market Surveillance Specialist

Description

Oxford Nanopore Technologies: Our goal is to bring the widest benefits to society through enabling the analysis of anything by anyone anywhere.

The company has developed a new generation of nanopore-based sensing technology for faster information rich accessible and affordable molecular analysis.

The first application is DNA/RNA sequencing and the technology is in development for the analysis of other types of molecules including proteins.

The technology is used to understand and characterise the biology of humans and diseases such as cancer plants animals bacteria viruses and whole environments.

With a thriving culture of ambition and strong innovation goals Oxford Nanopore is a UK headquartered company with global operations and customers in more than 125 countries!

We are looking for a proactive and highly collaborative Post Market Surveillance (PMS) Specialist to own the coordination of all post-market activities for our diverse product portfolio spanning both In Vitro Diagnostics (IVDs) and research use (RUO) products.

As our PMS Specialist you will be the core of our post-market operations. You will work cross-functionally with global teams to ensure our products maintain the highest standards of regulatory compliance.

The Role.

• You will take full coordination responsibility for our PMS activities providing vital and regular updates directly to senior regulatory affairs colleagues and the wider business.
• Your persuasive communication skills and collaborative approach will empower you to lead cross-functional teams and drive critical investigations.
• We want you to challenge the status quo. You will have the space to review our current PMS processes find efficiencies implement improvements and track changes in the regulatory landscape.
• You will collaborate with multi-disciplinary fast-paced teams who are located both in the UK and internationally.

Duties will include.

• Organise and run regular PMS activities aligned with our Quality Management System (QMS) regulatory requirements and international standards.
• Proactivity monitor complaint data for safety signals and act accordingly.
• Partner closely with customer and technical services to gather triage and escalate product and customer reports. You will also lead monthly reviews to spot trends and detect potential issues.
• Deliver the Health Hazard Assessments as part of our vigilance process requirements and generate required actions plans as necessary.
• Coordinate cross-functional teams to conduct deep-dive investigations analyse findings and write detailed reports to wrap up issues effectively.
• Maintain an active link between PMS findings and product risk management activities.
• Share your expertise by educating staff members on PMS requirements and contributing your insights to key management review meetings.

What were looking for.

You are a solutions-oriented professional who thrives in a fast-paced environment enjoys the challenge of managing change. You know how to break down complex scientific or regulatory details so they make sense to both technical and non-technical teams. You are comfortable operating with incomplete information and are able to formulate actions and responses to open questions.

Your Background:

• Education: You hold a science or engineering degree. (e.g. molecular biology engineering or other related fields).
• Experience: You bring 3 or more years of experience working within a regulatory affairs department in the diagnostics (preferred) or medical device industry with a strong focus on PMS processes.
• Regulatory Knowledge: You have a solid working knowledge of ISO 13485:2016 21 CFR ISO 14971:2019 and EU IVDR (or MDR) FDA and MDCG guidelines.
• Key Skills: You are a gifted writer a natural team player and a sharp problem solver who knows how to prioritize multitask and delegate.

If you are a positive driven regulatory professional who loves solving puzzles rather than just presenting problems we want to hear from you.

This is a hybrid role with office attendance being required on an occasional adhoc basis.

We offer outstanding benefits to include an attractive bonus generous pension contributions private healthcare and an excellent starting salary.

If you are looking to utilise your skills to really make a difference to humankind then consider joining our team and apply today!

Please note that no terminology in this advert is intended to discriminate on the grounds of a persons gender marital status race religion colour age disability or sexual orientation. Every candidate will be assessed only in accordance with their merits qualifications and abilities to perform the duties of the job.

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Required Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1