We've got a great role if you love regulatory work in SaMD (software as a medical device) and drug - device combination products. We need a Regulatory Affairs Officer / Manager for this. You will ideally need to be able to get to a King's Cross London office 10 days/ month. 

Our client is growing and has a really exciting new range of products for you to work on, supported by their expert team.

This position is responsible for carrying out a range of regulatory affairs duties to ensure company combination products are registered in required jurisdictions in a timely fashion and to ensure such licenses are maintained.

Primary Responsibilities:

• Support the Regulatory Director to ensure that company products being developed comply with regulations.
• Assist the creation of Regulatory strategies by helping to investigate regulatory requirements / changes in multiple jurisdictions
• Assist in the creation and update of Regulatory procedures
• Post market Regulatory activities
• Help ensure the team is kept up to date with changes to national and international legislation and guidelines.
• Support the preparation of submission dossiers and scientific advice briefings by helping to develop and write clear arguments and explanations for product licenses and license renewals
• Support the review of product information for compliance to global requirements
• Help ensure all trials and studies intended to be used for product claims meet regulatory requirements
• Provide regulatory support as needed for any regulatory authority inspections
• Act as primary point of administrative contact for the Regulatory team
• Perform miscellaneous duties as necessary for the effective completion of the position requirements

Qualifications:

Technical skills and abilities

• Educated to degree or equivalent level ideally within biological sciences
• Good understanding of device global regulatory requirements (FDA, EU, UK in particular) essential.

   

• Understanding / experience of combination product in these jurisdictions a distinct advantage
• Understanding of drug product in these jurisdictions and advantage
• Good experience within a Regulatory role in the Medical Devices industry.

   

• Experience of Software as a Medical Device (SaMD) experience with digital apps an advantage
• Experience of combination products a distinct advantage
• Experience of clinical aspects an advantage

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