Device Technical Regulatory Lead - Dublin

My client a global generic pharmaceutical company with a world wide presence is looking for a technical regulatory Lead to manage the, medical device sector of the business.

The technologies they develop enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and they work business wide to support innovative technology solutions to deliver healthcare to their patients

Your day to day duties include.

• Drive device regulatory strategies with respect to clinical development, commercial development and CTD submissions.
• Liaise closely with regulatory colleagues to deliver strategies for device elements of global filings, coordinate the content and delivery of technical documentation required to support filings in line with the relevant Regulations and Guidance
• Deliver strategy for regulatory agency meetings; develop technical briefing documents on device development and regulatory plans.
• Develop the patient Instructions for Use, and device labelling activities from the technical perspective. Liaise with regulatory and clinical functions to align with their needs whilst ensuring compliance to regulations.
• Subject Matter Expert in the application of FDA, EU and ISO standards and regulations related to design control and regulatory strategy.

To be considered you should have:

• Degree in a pharmaceutical development discipline, or equivalent.
• Proven experience in a pharmaceutical development environment, with a drug delivery/device focus.
• Experience in device development programs, specifically with a focus on the preparation and delivery of technical regulatory strategy and content
• Experience in drug product development, specifically with a focus on clinical interface, regulatory plans and high level strategy planning.
• Knowledge of device design controls, ISO/FDA requirements as applicable to device design.
• Be able to be away 20% travel in the UK& Ireland.
• Further 10% of global travel.

This position is based in Dublin but will require 30% travel across Europe (clients sites)

If this role is of interest to you then do not hesitate to get in contact today as my client is looking to select suitable CV's in the next week. Please send your CV in MS Word format (I am unable to accept PDF copies!) to me directly, Ruby Wallace, at r.wallace@nonstop-recruitment.com, or by calling me on 020 7940 2105 for a discussion in confidence.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.