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.
As the Regulatory Affairs Specialist you will be responsible for maintaining the integrity and compliance of medicinal product imports, ensuring the highest standards are met in line with industry regulations.
We are currently looking for a Regulatory Affairs Specialist to join a leading Distribution company based in the Kent area.
This will be a hybrid role consisting of 3 days on site and 2 days working from home.
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.
A Regulatory Specialist is urgently required or the responsibility of providing global regulatory and scientific support for new and existing products, raw materials and processes.
In this role as a Regulatory Affairs Officer, you will be responsible for building regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements, and managing product license registration with the appropriate regulatory authorities worldwide.
An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department.