Direct message the job poster from Pale Blue Dot Recruitment Limited
Pale Blue Dot Recruitment | The Experts in MedTech Recruitment
Our Client, a leading Medical Device company based in Clare, is seeking a Senior Regulatory Affairs Specialist to join their team. This position will be responsible for developing and implementing regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products.
Responsibilities include but are not limited to:
* 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.
* Coordinate multiple projects at one time and provide 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 labeling/instructions for use for compliance with applicable local and international regulations.
* Recommend changes for labeling and internal documentation, reports for regulatory compliance.
* Keep abreast of regulatory procedures and changes. Support the review of internal procedures to ensure continuous compliance with all regulatory requirements.
* May have direct interaction with regulatory agencies on defined matters.
* Support regulatory compliance activities, including manufacturing site registration and GMP audits as needed.
* Identify and develop best practices within the Regulatory Affairs Department, including continuous development initiatives.
* Coordinate gap assessments against regulatory requirements.
* Communicate status of projects/submissions directly to senior management as required.
Biological Evaluation Specific:
* Support/prepare biological evaluation plans and reports for marketing, regulatory affairs, clinical affairs design review, post-market surveillance, and reimbursement purposes.
* Become the Subject Matter Expert (SME) for the company's Biological safety process.
* Coordinate multiple projects at one time and provide regular reports to regulatory management, clinical affairs, and others as required.
* Work closely with Regulatory and Clinical Affairs to address biological aspects for submissions to EU/US regulators, including responding to requests from Regulators.
* Maintain an excellent understanding of the global medical device regulations, especially with respect to Biocompatibility, for example, ISO 10993, and identify and critically assess emerging standards, theories, and methodologies, applying gained expertise within the company's Biological safety processes.
* Coordinate with external biological laboratories on testing required and compile requirements to conduct the same, for example: samples, quotes, critical review of protocols, reports, etc.
* Communicate with consultants/toxicologists/peer review within the company as necessary.
* Design and conduct literature searches on products, specific surgical indications, outcomes, or other areas.
* Be a primary contact for biological working groups/training going forward.
* Support pre-clinical and clinical activities as required.
* Conduct comprehensive evaluations of biological risks associated with medical devices, ensuring compliance with ISO 10993 and regulatory requirements.
* Develop and oversee biocompatibility testing strategies, including material characterization, in vitro, and in vivo studies.
* Ensure alignment with global regulatory standards (FDA, EU MDR, ISO 14971) and support risk management file development.
* Work closely with R&D, Quality, and Regulatory teams to mitigate biological risks and support product development and submissions.
Job requirements:
* Level 8 Honor’s Degree in Science or Engineering bachelor’s degree/master’s with a minimum of 3-5 years relevant experience with medical devices.
* 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.
* You are a dynamic team player and can work effectively and proactively on activities both individually and in teams.
-Pale Blue Dot Recruitment - The Resource for the MedTech Workforce-
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Engineering, Project Management, and Quality Assurance
Industries
* Medical Equipment Manufacturing and Biotechnology Research
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