Post Market Surveillance Manager

1 month ago

Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

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.
Oxford Nanopore employs from multiple subject areas including nanopore science, molecular biology and applications, informatics, engineering, electronics, manufacturing and commercialisation. The management team, led by CEO Dr Gordon Sanghera, has a track record of delivering disruptive technologies to the market.
Oxford Nanopore's sequencing platform is the only technology that offers real-time analysis, in fully scalable formats from pocket to population scale, that can analyse native DNA or RNA and sequence any length of fragment to achieve short to ultra-long read lengths. Our goal is to enable the analysis of any living thing, by anyone, anywhere
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 important role, you'll be involved in a range of duties including providing support to the Regulatory Affairs Managers and Senior Director and interfacing 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 gathered, 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.
  • Create 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 3 or more years of experience working in a regulatory affairs team within the diagnostics industry.
A strong working knowledge of 21CFR, IVDR and ISO 13485 will be critical for the role.
The successful applicant will display key skills such as strong communications, 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.

We offer outstanding benefits to include an attractive bonus, generous pension contributions, private healthcare and an excellent starting salary. Based within beautiful, landscaped surroundings with tree-lined walks, water features and a lake, all of which make for a wonderful working environment.
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 person's 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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