Snr Regulatory Affairs Specialist

ICDS Recruitment

Galway

Senior Regulatory Affairs Specialist (Medical Devices) - Galway. Senior Regulatory Affairs. The Senior Regulatory Affairs Specialist will provide guidance to product development teams engaged in the design of minimally invasive cardiovascular medical devices that are legally manufactured by Creganna Medical. He/she will ensure that compliance to regulatory requirements is demonstrated and will provide on-going regulatory support through the product life cycle. Job Responsibilities: · Provides regulatory guidance in support of medical device product development. · Plans, prepares and submits regulatory submissions for US Class II products and MDD Class IIa, IIb and III products, including 510(k), design dossier and technical files to the relevant regulatory aurthorities. · Provides post-approval regulatory affairs support of medical device products throughout their commercial life. Reviews product and process changes. · Creates and maintains regulatory filings. Ensures that Design Dossiers and Technical Files are maintained up to date. · Updates and generates Clinical Evaluation Reports to align with Meddev 2.7.1 Rev 4 Clinical Evaluation. · Performs (clinical) literature searches under guidance and interprets the outputs for safety, performance and efficacy consideration. · Conducts complaint adverse event reporting assessments and reporting activities for CTM legally manufactured products, including vigilance and eMDR reporting. · Generates Post Market Surveillance Reports for a CM Legally Manufactured devices to a schedule. · Supervises Regulatory Affairs Administrator with responsibility for international registrations performed by a third party. · Updates quality system as required for regulatory specific changes. · Participates in and assists with external regulatory agency audits, as required. · C-ordinates Field Safety Corrective Actions as required. Key Requirements: · Must have a minimum of 5 years of medical device regulatory affairs experience with a Bachelors degree or higher in a related discipline. Bachelor's degree in science, , engineering, or medical fields is preferred. · Demonstrated knowledge of the Medical Device Directive MDD 93/42/EEC, US FDA 21 CFR Regulations, ISO 13485 and ISO 14971 at a minimum. · Previous experience in a Design Assurance role an advantage. · Must be able to work independently and as a member of a cross-functional team; exhibiting attention to detail, multi-tasking and time management skills to meet high expectations and tight deadlines. · Strong interpersonal skills and the ability to communicate well both internally and externally to Creganna. · Demonstrated computer skills – word processing, spreadsheets, internet research and other applicable software programmes (Microsoft Word, Excel, PowerPoint. · Must have excellent report writing skills; the ability to deliver a clear, precise message appropriate to the target audience. · Must keep excellent records and traceability to data supporting decision making. This job originally appeared on RecruitIreland.com.

2689 days ago