A Major Medical Devices Company in Galway, Ireland wish to recruit a suitably qualified person for the following post:
SENIOR REGULATORY AFFAIRS SPECIALIST
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 labeling, 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 (MOS/COS)
KEY SKILLS & EXPERIENCE
Bachelors 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 and/or Pharma 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
REMUNERATION: Excellent Salary/Benefits Package on offer and negotiable
Please forward CV immediately to:
For informal enquiries, please phone Christy O'Hara on 087-9473404 and if outside Ireland 00353 87 9473404