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 standardsSkills 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 standardsPlease click 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.

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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 | OC(phone number removed) England and Wales