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Regulatory Affairs Specialist
1 week ago
Regulatory Affairs Specialist Excellent opportunity for a Senior Regulatory Affairs Specialist to join a thriving company in Co. Clare.
The Senior Regulatory Affairs Specialist will be responsible for developing and implementing regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products.
The Senior Regulatory Affairs Specialist will also provide support to the functional project teams on Biological Evaluations for new and existing products/indications and will be responsible for implementing biological evaluation plans.
Key Responsibilities: Lead the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
Respond to requests from notified bodies; competent authorities and/ or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
Provide regulatory direction to development project teams as a core team member.
Advise other functional units (engineering, marketing, operations, quality etc) of the requirements in each target market.
Review proposed labelling/instructions for use for compliance with applicable local and international regulations.
Recommends changes for labelling and internal documentation, reports for regulatory compliance.
Become the Subject Matter Expert (SME) for the Biological safety process.
Coordinates multiple projects at one time and provides regular reports to regulatory management, clinical affairs and others as required.
Works closely with Regulatory and Clinical Affairs to address biological aspects for submissions to EU/US regulators, including responding to requests from Regulators.
Maintains an excellent understanding of the global medical device regulations especially with respect to Biocompatibility for example ISO 10993, and by identifying and critically assessing emerging standards, theories and methodologies and applying gained expertise within the Biological safety processes.
Conduct comprehensive evaluations of biological risks associated with medical devices, ensuring compliance with ISO 10993 and regulatory requirements.
Key Requirements: Level 8 Degree or Masters in Science or Engineering or similar Minimum of 3 years experience in a similar role in the medical devices industry.
Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required.
Understanding of applicable guidelines and regulations, for example experience with ISO 10993 Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements.
Ability to effectively manage multiple projects and priorities.
Has an excellent attention to detail and are results oriented.
For further information please contact Loretta Flynn INDCRG Skills: regulatory affairs ISO 10993 EU MDR Biocompatability biological plans
