The Senior Regulatory Affairs Specialist will provide support to the functional project teams on Biological Evaluations for new and existing products/indications. The role will involve implementing biological evaluation plans and reports to meet business targets, participating and interacting with project groups ensuring MDD/MDR Compliance, assisting with pre-clinical and clinical submissions and departmental projects as assigned.
About Your New Job as a Senior Reg Affairs Specialist:
* Responsible for providing support for assigned biological evaluation projects for both internal and external customers.
* 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.
* 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.
* Keeps abreast of regulatory procedures and changes. Support 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 & GMP audits as needed.
* Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives. Co-ordinate gap assessments against regulatory requirements.
* Communicates status of projects/submissions directly to senior management as required.
What Skills You Need to succeed as a Sr Reg Affairs Specialist:
* Level 8 Honour’s Degree 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 pro-actively on activities both individually and in teams.
Seniority level
Associate
Employment type
Full-time
Job function
Manufacturing and Engineering
Industries
Medical Equipment Manufacturing
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