Senior Regulatory Specialist

4 days ago

Abingdon, United Kingdom Coburg Banks Limited Full time

A high-growth global healthcare company is currently looking for a Senior Regulatory Specialist to join their UK headquarters in Abingdon, Oxfordshire. You would assist the Director of Regulatory Affairs and the Head of Regulatory Affairs with the company'sregulatory process, leading to timely product approval for both new and existing products.
The role will suit individuals with significant experience within IVD/MD Regulatory Affairs, with substantial previous submissions experience, ideally in a medical device/diagnostics field, including experience with some or all of US FDA, EU, China NMPA, andJapan PMDA.
Offering an attractive salary dependent on experience plus benefits including bonus, pension scheme, plus life and medical insurance, this is a fantastic chance to contribute to great science driven by intellect and curiosity, and work with great people unitedin doing important work and being valued for it.
**The Role**
The company house the only national TB testing laboratory exclusively dedicated to performing the T-SPOT.TB test and are committed to providing the highest quality results and service to customers and patients.
As Senior Regulatory Specialist you would play a key role in regulatory process, providing global regulatory support to Sales and Commercial teams for ongoing requests for documents and information. Key tasks will include
- Ensuring verification / validation activities plus risk management are carried out to support regulatory requirements
- Supporting facilities to ensure that any regulatory needs are covered
- Assisting with Internal and External audits to agreed standards, with regard to the regulatory requirements
- Taking a central role in the preparation for and implementation of the requirements of global IVD Regulations
- Educated to degree level or higher or with significant relevant experience within IVD/MD Regulatory Affairs
- Excellent knowledge of Quality Management systems, especially ISO 13485 and cGMP
- Substantial previous submissions experience, ideally in a medical device/diagnostics field, and including experience with some or all of US FDA, EU, China NMPA, and Japan PMDA
- Understanding of the scientific, biological and technical issues involved in developing diagnostic assays
- Experience in the line management of junior staff
- Experience of the conduct of Internal and External Quality audits
- Ability to operate at manager level and demand respect of peer group
**The Company**
Across the globe, the company is driven by the expectation of excellence. Their proprietary immunology platform is already generating a major impact on human life by creating more effective ways to test for diseases like TB and transforming the diagnosticsmarket place in the process. At the same time, in their commitment to giving passionate and creative people the freedom to explore their full potential they are working to set a new standard for careers in the sector.
IND3Coburg Banks Limited is acting as an Employment Agency in relation to this vacancy.

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