In Vitro Diagnostics – Regulatory Specialist

Location: Oxfordshire

Duration: 9 month FTC

Salary: Annual salary equivalent of £40-50,000 (pro-rated for 9 months)

Sector: Diagnostics

Our client is a global biotechnology company specialising in the development of immunological products to diagnose and monitor patients with immunologically controlled diseases.

The role:

An opportunity has become available for an Regulatory Specialist, experienced in Diagnostics, to join company and support the Global Regulatory activities in order to facilitate timely approval of new and existing products.

Core duties will include:

• Support with verification and validation activities to support global regulatory requirements.
• Assist the quality and regulatory team in preparation of documents for the Global IVD regulations.
• Maintenance of international quality certifications to ensure compliance (ISO13485, ISO17025, GMP)
• Assist with communication with Regulatory authorities to ensure compliance with IVD regulations
• Support with regulatory communications internally and across departments.

Experience expectations:

The successful applicant will ideally have;

• Prior experience as a Regulatory Specialist within IVD or Medical Devices
• Excellent understanding of ISO13485, ISO17025 and cGMP
• Familiarity in regulatory submission processes within Medical Devices or diagnostics.
• Familiarity with EMEA and LATAM regions is beneficial.
• Experience of internal and external quality audits
• Ideally educated to BSc (or equivalent) in a relevant Biological discipline
• Excellent written and oral communication skills

The Package:

My client is offering a 9 month Fixed Term Contract with an annual salary equivalent of £40,000-£50,000 (dependent on experience).