As a Regulatory Affairs Executive, your role will be instrumental in supporting the administrative backbone of the department, maintaining the precision of the regulatory database, and orchestrating the preparation and tracking of regulatory submissions across various stages.
Are you looking for a new opportunity where your expertise will be pivotal in navigating the complexities of UK/EU regulatory frameworks?
Based in Berkshire, this role offers the chance to become an integral part of a leading Pharmaceutical company, ensuring that innovative health solutions reach the market efficiently and safely.
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.
We are looking for a regulatory affairs professional to join a chemical products manufacturing business.
Key elements of the role include regulatory research and analysis, maintenance of key chemical regulatory documents, compilation of regulatory dossiers to support product approval globally and, authoring and maintenance of safety data sheets.
This is a challenging and diverse role within a friendly regulatory team that offers excellent career development.
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 role is responsible for the delivery of the company's development regulatory roadmap.
About the Company
We are an innovative medical devices manufacturer of advanced wound care products, including combination products, from gelling fibres and fabrics.
We deliver innovative, cost effective and quality products and solutions for the advanced wound care industry helping to improve patient care and wellbeing.
If you are looking for a step up in your current role then please apply below to be considered for the Regulatory Affairs Officer role.
An exciting opportunity for an experienced Regulatory Affairs Officer to join a global company in the North West.
As a Regulatory Affairs Officer you will be responsible for product compliance following UK and EU REACH guidelines and acting as a mentor to less experienced staff.