Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

My client a leading medical device manufacturing company is looking for hire a Senior Regulatory Affairs Specialist on a permanent basis.

Purpose

In the  Regulatory Affairs department we focus on harnessing our collective strength to deliver best-in-class solutions that benefit patients and our cross functional partners. Senior Regulatory Affairs Specialists are directly involved in regulatory activities supporting the global commercialization and sustaining of products on the market in compliance with all regulatory requirements.

Key Responsibilities

• Directs or performs coordination and preparation of document packages for regulatory submissions.
• Teams with business unit Regulatory Affair Specialists and international regulatory colleagues to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
• Compiles materials required for submissions, license renewal and annual registrations.
• Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
• Recommends strategies for earliest possible approvals of clinical trials applications.
• Keeps abreast of regulatory procedures and changes.
•  May direct interaction with regulatory agencies on defined matters.
•  Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
• Identify and develop best practices within the Regulatory Affairs department including continuous development initiatives

Key Requirements

• Bachelor’s degree required (Level 8)
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
• Experience in Medical device is essential
• Works directly on regulatory files for USA / EU.  Experience working directly with FDA, notified bodies in the European Union and International Regulators preferred.
• Experience working with Class III medical devices
• Experience with product change control
• Knowledge of new Medical Device Regulation in European Union.
• Lead projects/programs on own initiative
• Proficient with Microsoft applications including, Sharepoint, Teams, and knowledge of Adobe Acrobat, Data Management Systems are desirable

For more information on this Senior RA Specialist position please contact Clara Burke on 086 8168273/ science@hero.ie 

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