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.
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.
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.
We are looking for a high calibre recent graduate who is looking to start a career in field of chemical regulatory affairs and risk assessment.
This team are experts in chemical risk assessment; they enable their global clients to effectively manage the risks posed by chemical to the environment and human health, and to fulfil their legal obligations under regulations such as REACH and CLP.
You will join an experienced multi-disciplinary team working in the field of chemical regulatory science; full training will be provided enabling you to fast track your career in this exciting and evolving area.
Your role will involve working closely with not only the team but also with General Managers, Hospital Directors and Regional Directors to support them to provide responses to regulators in a timely and efficient manner.
As an integral part of the team at Barchester, you'll deliver a professional, business-focused service to our Regulation and Quality Improvement Team.
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.
An opportunity for an Ecotoxicology / Environmental Sciences Graduate looking to start a career in regulatory ecotoxicology and regulatory science.
Full training will be provided in all aspects of regulatory ecotoxicology and chemical regulatory affairs - become an expert on REACH, CLP, and other chemical regulations.
This is an amazing career opportunity - it is a desk-based role working with ecotoxicology / environmental toxicology data, assessing the ecotoxicity of chemicals to ensure regulatory compliance.
Ideally you will have experience in GLP ecotoxicology studies - and be interested in moving to the next stage - using the study data for regulatory affairs and risk assessment.
An opportunity for an Ecotoxicology Study Scientist or researcher to move into a desk-based risk assessment role with a successful chemical risk assessment consultancy.
Full training in chemical regulatory science will be provided - a rare opportunity.