Senior Regulatory Specialist (CR/4004712) Cork, Republic of Ireland
Salary: EUR70 - EUR75 per hour
We’re looking for a Senior Regulatory Affairs Specialist for a fast-growing med tech company based in 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.
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