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.
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.
Senior Regulatory Affairs Specialist opportunity working for a growing pharmaceutical company that specialising in medicinal, non-medicinal, medical devices, and OTC products.
Employment Type: Permanent, Full time
The business is increasingly growing and is looking for a personable and detail-oriented professional to join the team.
We are a global wound care manufacturer, looking to appoint a knowledgeable and experienced Regulatory Affairs Specialist to our growing team.
Do you possess a strong understanding of medical device regulations, coupled with at least 3 years' experience in medical device regulatory affairs and MDR?
Key responsibilities for the Regulatory Affairs Officer
Ensure Regulatory compliance with drugs imported overseas.
Lead any changes within the regulations and ensure the QMS is complaint with these.
General
I am currently working with a Parrell Import organisation based in North East London, this is a great opportunity for someone wanting to progress their career and join a friendly team.
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.