Medical Devices Coordinator
5 days ago
Sigmar Recruitment is seeking an experienced Senior Regulatory Affairs Specialist to join our team.
This employer is a strategic partner for small to large companies, physicians, universities and government-funded projects to advance the development of life-changing medical technologies.
The Senior Regulatory Affairs Specialist will be responsible for providing support to the functional project teams on Biological Evaluations for new and existing products/indications. This 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 the Role:
- Provide 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.
- Recommends 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 between against regulatory requirements.
- Communicates status of projects/submissions directly to senior management as required.
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