Senior Regulatory Specialist

We're looking for a Senior Regulatory Affairs Specialist for a fast growing med tech company based Cork (Ireland). The successful candidate will collaborate with cross-functional teams to facilitate regulatory approvals, manage submissions, and maintain compliance with evolving regulatory requirements. This position offers an excellent compensation package and potentially hybrid working.

Responsibilities

• Regulatory Strategy Development: Formulate and execute strategies for product registration, approval, and compliance
• Daily Regulatory Management: Oversee day-to-day regulatory activities and manage multiple projects related to regulatory compliance
• Submission Management: Prepare, maintain, review, and submit regulatory documents and applications to health authorities
• Global Registration Support: Assist the team in obtaining and retaining country-specific regulatory registrations worldwide
• MDSAP Implementation: Manage the implementation of the Medical Device Single Audit Program within the organization
• Regulatory Compliance Monitoring: Ensure compliance with national and international regulatory requirements and quality standards
• Risk Assessment: Identify and assess potential regulatory risks and propose effective mitigation strategies
• Cross-Functional Collaboration: Work closely with QA, R&D, Operations, Clinical Affairs, and other departments to integrate regulatory requirements into QMS and product development processes
• Regulatory Updates: Stay current with changing regulations, guidelines, and industry trends
• Maintain high-quality standards within the organization by assessing risk profiles and creating mitigation programs/tools.
• Post Market Surveillance: Manage activities including logging customer complaints and adverse events, coordinating investigations, and conducting regulatory trending and reporting
• CE Mark Submissions: Handle submissions, significant change notifications, and interactions with Notified Bodies
• International Filings: Support the team with the preparation of international regulatory filings, including 510(k) submissions and FDA correspondence
• Material Review: Ensure public-facing materials comply with regulatory standards

Skills and Qualifications

• Bachelor's degree in Engineering or Science or practical expertise
• Regulatory experience in the medical device industry
• Understanding of ISO 13485, ISO 14971, EU MDR, UK, MDSAP, 21 CFR 820, and supporting standards

Please visit our website to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.

To find out more about Real, please visit our website

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales