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Job Description
Oxford Nanopore Technologies is headquartered at the Oxford Science Park outside Oxford, UK, with satellite offices and a commercial presence in many global locations across the US, APAC and Europe.
Reporting to the Regulatory Affairs Manager, this role will be responsible for the co-ordination of all required post-market activities. Through working across the organisation, the role will assure that post market surveillance activities as defined in the OND Quality Management System (QMS) are applied and completed according to defined regulatory reporting timelines. This role is intended to take full coordination responsibility and provide regular report updates to the regulatory affairs manager and the wider business.
The Details...
In this meaningful role, you'll be involved in a range of duties including providing support to the Regulatory Affairs Managers and Senior Director and collaborating with departments across the business to help fulfil our post market obligations.
Key responsibility areas are:
* Organisation and co-ordination of post market surveillance tasks aligned to OND QMS policies, procedures, processes, and international regulations.
* Ensuring that the requirements of individual products Post Market Surveillance plans are met.
* Work closely with OND technical services and external key strategic partners to ensure PMS information is captured, triaged, escalated, and completed appropriately.
* Coordinating cross functional teams to ensure investigations that include detailed information gathering, analysis and reporting are conducted and concluded satisfactorily.
* Working with the Regulatory Affairs Manager, establish and maintain PMS information sources for actively gathering customer feedback, monitoring, and reporting of product field performance.
* Provide information in a timely manner to the Regulatory Affairs Manager for use in the development of any required vigilance reporting.
* Educate other members of staff in the requirements of PMS activities.
* Work alongside the Regulatory Affairs Manager and Quality Assurance team to maintain PMS procedures and processes and propose process enhancement/improvements where necessary.
* Build PMS reports, with updates as required by those products PMS plans.
* Contribute to management review meetings through preparation and presentation of PMS information.
What We're Looking For...
We'll expect you to have a good grounding in IVD device regulations, specifically post market surveillance requirements with several years' experience working in a regulatory affairs team within the diagnostics industry. A strong & solid understanding of 21CFR, IVDR and ISO 13485 will be essential for the role.
The successful applicant will display key skills such as strong communication, excellent writing skills, effective team worker across multi-disciplinary teams, excellent analytical / problem solving skills along with strong persuasion skills and ability to make and take decisions but also understanding of when to escalate.
If you are looking to utilise your skills to really make a difference to humankind, then consider joining our team and apply today!
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