Our client a leading manufacturing company in Galway requires a Senior RA Specialist for a fixed term contract job. This job will provide guidance to product development teams engaged in the design of minimally invasive cardiovascular medical devices. And also to ensure that compliance to regulatory requirements is demonstrated and will provide on-going regulatory support through the product life cycle.
- 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 authorities.
- 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.
- Updates quality system as required for regulatory specific changes.
- Participates in and assists with external regulatory agency audits, as required.
Education, Experience and Skills
- Must have a minimum of 5 years of medical device regulatory affairs experience with a Bachelor?s degree or higher in a related discipline.
- 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
For further information on this Senior Regulatory Affairs Specialist role in Galway please contact Cliona O?Malley on 091730022 / firstname.lastname@example.org
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