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.
An opportunity has now become available for an experienced Regulatory Affairs Manager to join the company and undertake a leading role in product compliance with industry standards and regulatory requirements.
As a fully regulatory compliance facility, our client are able to provide technical innovation supporting with the formulation and development of novel cleaning products across many sectors.
Our client is an established contract manufacturing organisation (CMO) providing services on a global scale.
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.
Your duties as the Head of Regulatory Affairs and Pharmacovigilance will be varied however the key duties and responsibilities are as follows:.
General
As the Head of Regulatory Affairs and Pharmacovigilance you will be responsible for providing organisation with strategic advice for the launch of new products in EU & UK..
We are currently looking for a Head of Regulatory Affairs and Pharmacovigilance to join a leading Pharmaceutical company based in the Kent area.
As the Regulatory Affairs Manager you will be responsible for EU regulatory activities including lifecycle management, submissions to EU regulatory bodies, preparing for new MAAs and developing regulatory strategy (throughout product lifecycle).
Walker Cole International is searching for a Regulatory Affairs Manager to join a global pharmaceutical company.
The main responsibilities of the Regulatory Affairs Manager will include
Module 1 compilation, artwork management & approvals, submission of new Marketing Authorizations.