Senior Regulatory Affairs Specialist
4 hours ago
I'm pleased to have partnered exclusively with a market leading and rapidly growing diagnostics company who are focused on developing and commercialising proprietary assays for infectious diseases. Their latest in-vitro diagnostic device has been approvedin over 50 countries where the product is used to diagnose one of the worlds largest cause of death of from infectious disease.
**Senior Regulatory Affairs Specialist Role**:
As Senior Regulatory Affairs Specialist, you will work as part of close-knit and multiskilled team of Quality and Regulatory professional reporting into the Director or Regulatory Affairs with the company's regulatory process leading to timely product approvalfor both new and existing products in line with company goals. In addition, you will provide global regulatory support to sales and commercial teams for ongoing requests for documents and information.
**Senior Regulatory Affairs Specialist Responsibilities**:
- To take a central role in the preparation for and implementation of the requirements of global IVD regulations
- Assist with the conduct of internal and external audits to agreed standards in line with regulatory requirements
- To work with the compliance manager ensuring verification and validation activities are carried out to support global regulatory requirements
- Take a central role with documentation and regular communication with regulatory requirements
- Assist with the maintenance of certification to international quality standards for medical devices, clean room and production environments
- Review of sales and marketing documents from the regulatory perspective
- Clear operation of across departments to resolve regulatory related issues in collaboration with pee group and senior members of staff
**Senior Regulatory Affairs Specialist skills**:
- Degree qualified with a Life Science qualification
- Minimum of 6 years' experience within a regulatory role within the medical device sector with exposure to IVD's
- Excellent knowledge of Quality Management Systems especially ISO 13485 and cGMP
- Well versed in the creation of technical files with numerous global submissions
- Strong understanding of the scientific, biological and technical issues involved in developing diagnostic assays
- Experience in the line management of junior members of staff
- Experience conducting internal and external audits (certified auditor beneficial)
- Attention to detail
- Ability to work with mínimal supervision
- Excellent written and verbal communication skills
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