Job Reference: J5631742
Updated On: 27/06/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Regulatory Affairs Consultant who specialises in Inhalation / respiratory medical device products to join a leading Medical Devices company based in the Cambridgeshire area on a 1 day per week contract. As the Regulatory Affairs Consultant you will be responsible for providing specialist advice and information of regulatory and licensing procedures.
Key Duties and ResponsibilitiesYour duties as the Regulatory Affairs Consultant will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for completing, maintaining, and delivering all regulatory documents including MHRA licences, DMF etc.
2. As the Regulatory Affairs Consultant, you will be responsible for maintaining drug and device registrations with the FDA to ensure they are up to date to enable the company to continue supplying products to the US markets.
3. You will be responsible for providing direction, advice, training and guidance to employees regarding compliance and regulatory issues, including he review and implementation of QMS transactions.
4. As the Regulatory Affairs Consultant, you will be working in the regulatory team on site to help make decisions to help support this team.
Role RequirementsTo be successful in your application to this exciting opportunity as the Regulatory Affairs Consultant we are looking to identify the following on your profile and past history:
1. Proven industry experience in Regulatory Affairs in the US markets (FDA).
2. A working knowledge and practical experience with Respiratory / Inhalation products.
Key Words: Regulatory / Consultant / Contract / FDA / US / Markets / Respiratory / Inhalation / QMS / MHRA/ Medical Devices / Med / Devices / Inhalers / Cambridge / Cambridgeshire
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