We are seeking a talented Regulatory Affairs Specialist to join our client's regulatory team in support of the expansion of their ISO 13485 diagnostics product pipeline.
Reporting to the Regulatory Affairs Manager, you will play a crucial role in ensuring regulatory compliance and supporting the successful submission of our products to global regulatory agencies.
As Regulatory Affairs Specialist responsibilities include
Collaborate closely with the Regulatory Affairs Manager to develop and maintain technical files and submissions for global regulators.
The successful Regulatory Affairs Specialist / RA Specialist will have hands-on knowledge of FDA regulations, ISO standards & SaMD - as well as proven experience working with medical devices that use AI & Machine Learning.
Regulatory Affairs Specialist, RA Specialist, FDA, 510(K), SaMD, Remote, COR5716
This is an excellent Regulatory Affairs Specialist / RA Specialist, working for a company with a growing reputation in their field.
This is an excellent opportunity to join a leading medical device manufacturing that is the world leader in Glucose Monitoring, their ranging product portfolio, develops and manufactures glucose monitoring systems for use in both home and hospital settings.
With a diverse, global network serving customers in more than 160 countries, the organisation creates new solutions across the spectrum of health, around the world, for all stages of life.
As the Quality and Regulatory Specialist, you will play a pivotal role in my client's mission to deliver groundbreaking solutions in global diagnostics.
TEC Partners is pleased to have partnered with a pioneering medical device company who is set to pave the way for AI-based automated analysis software to overcome a global crisis affecting millions of lives.
An opportunity has become available for an Regulatory Specialist, experienced in Diagnostics, to join company and support the Global Regulatory activities in order to facilitate timely approval of new and existing products.
General
Sector: Diagnostics
Our client is a global biotechnology company specialising in the development of immunological products to diagnose and monitor patients with immunologically controlled diseases.
We are seeking a career minded Quality and Compliance Assistant to assist our Head of Compliance in key areas within the organisation including Quality, Commercial, Environmental, Health and Safety,
The role offers significant scope for the development of a wide range of experience and competencies relating to working in a high performing logistics and installation business compliant with ISO 9001, ISO 14001 and ISO 45001, under the direction of a very competent and experienced senior management team.
We are a small team running a very successful and unique business, part of a worldwide Group but very much focussed on the UK market from our purpose built logistics centre and Headquarters near Didcot.
The range of duties encompass Horizon scanning - monitor regulatory or legislative changes which may affect the business and pro-actively share insight through regulatory updates.
A highly established Insurance group are focused on finding an experienced Risk and Compliance Officer to work on a Hybrid basis.
Duties will include: Assist partners and senior lawyers with their caseload of files dealing, effectively with cases and transactions.
We currently have an opportunity for a Solicitor to join our Oxford Industrial Disease team.
Our Industrial Disease team specialise purely in assisting sufferers of asbestos-related diseases, including mesothelioma, lung cancer, asbestosis and diffuse pleural thickening, and their families