Regulatory Affairs Specialist
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The Regulatory Affairs Specialist will play a pivotal role in ensuring the company's products meet and exceed internal and external regulatory standards, contributing to long-term success.
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This is a permanent position with an immediate start, offering a unique opportunity for growth and innovation in the healthcare industry.
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Key Responsibilities:
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* Ensure all products are compliant with regulatory requirements within the current market.
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* Manage regulatory changes connected to UKCA and MDR, as well as monitor evolving global regulations.
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* Maintain audit readiness for customers, HPRA assurance, WHO inspections, and supplier audits.
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* Lead strategic quality improvement projects to strengthen the company's long-term success.
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* Oversee Design Control, Change Control, Risk Management, Product Vigilance, and Document Control Systems.
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* Assess device/quality systems changes and manage corresponding assessments.
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* Promote ISO Quality Management certification by managing correspondence with Notified Bodies.
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Requirements:
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* A minimum of 3 years' experience in a regulatory position within the medical device/healthcare industry.
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* Qualification in Regulatory Affairs or a related field is essential.
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* A self-starter with minimal supervision needs.
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* Strong knowledge of ISO, MDD, MDR & CE/UKCA.
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* Excellent time management, attention to detail, and systematic approach to process review.
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Estimated Salary: $80,000 - $110,000 per annum, depending on location and experience.