Our client a medical device company in Galway is looking to hire a Senior Regulatory Affairs Specialist on a contractual basis for 12 months.
Responsibilities may include the following and other duties may be assigned.
- Directs or performs coordination and preparation of document packages for regulatory submissions.
- Teams with business unit Regulatory Affair Specialists and international regulatory staffs 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.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
- Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
- 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)
- Bachelors degree required
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
- Experience in Medical device or Pharma is essential
- Experience or working with regulatory files for USA / EU
- Lead projects/programs on own initiative and filed them
- Experience working directly with FDA, and notified bodies in the Europe
- Experience working with Class III medical devices or DMS Drug master file
- Experience filing using the ECTS system
- You are experienced with Microsoft applications including Word, Excel, Sharepoint, Teams, and knowledge of Adobe Acrobat, Data Management Systems are desirable
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