Regulatory Affairs Specialist Medical Device North West £CompetitiveSRG are currently recruiting for a Regulatory Affairs Specialist to join a Global Medical Device company in the...
Provide comprehensive support to the Regulatory Affairs and Clinical Operations teams to coordinate the logistical and regulatory aspects of the clinical trials in compliance with ICH GCP/company SOPs.
- Involved in clinical trial activities - specifically preparation for study site set up, conduct and close out of a clinical trial and provide administrative support to the Clinical Team specifically with regard to collating trial master files, implementing and maintaining spreadsheets and databases for tracking patients and clinic visits.
- Assist with the Ethics/Regulatory Submissions; keeping a track of submissions & approvals for the study, using IRAS and CESP.
- Maintain information on worldwide regulatory requirements and the status of product registrations and Liaise with all departments and project teams to co-ordinate timely applications for regulatory approvals.
- Setting-up and maintaining Trial Master Files, Investigator Site Files and QMS documents and folders according to current SOPs and indexes.
- Assist in the tracking and distribution of safety reports and safety information to investigator sites according to SOPs and prevailing law.
- Work with Finance to implement and maintain systems scheduling payments to clinical trial sites and regulatory authorities in a timely manner.
- Work with the CRA, VP Clinical and HC&R for the production of clinical study materials and the GMP Production Manager and Clinical Research Associate to ensure both production and treatment schedules are fully aligned.
- Maintain filing/retrieval systems and the uploading and downloading of documentation to dedicated company files. Arrange transfer of documents from the Trial Master File to the ISF.
- Ensure quality management systems are fully integrated between Clinical and GMP Operations e.g. would include integration of vendor review/approval and maintenance and supply agreements, CTA Agreements, CRO Agreements and SOPs.
- Experience in life sciences sector or educated in life sciences field
- Experience in Regulatory application process, dossier preparation using Integrated research Application System and Central European Submission Platform.
- Experience of Quality Management Systems and knowledge of ICH GCP, GM
If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.