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.
Are you a Senior Regulatory Specialist / Regulatory Affairs Manager who would you like to work with a fast-growing business with lots of technical development planned for the next 3 years??
The role of Senior Regulatory Specialist offers you the chance to work with a globally recognised business with a strong client base who are even having to currently turn down work!
Do you have regulatory affairs experience within the medical devices sector?
An excellent role on offer for an individual with strong regulatory affairs experience within the medical device sector looking to play a key role at an industry leading company.
Would you like to work for a world leading company?
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.
Yolk Recruitment is partnered with a pioneering medical device business during an exciting period of sustained expansion and has a new opportunity for a Regulatory Specialist to join the team.
The role offers not only the opportunity to be a part of a high growth, high innovation business in a rewarding field, but to make your mark in a lead role providing guidance on a wide range of regulatory affairs.
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.