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Senior Regulatory Affairs Specialist

Job Title: Senior Regulatory Affairs Specialist
Contract Type: Permanent
Location: Galway
REF: 87046
Job Published: over 1 year ago

Job Description

Contact: Cliona O'Malley
Telephone: 091730022

Senior Regulatory Affairs Specialist
My client is looking for a Senior RA Specialist in Galway. This RA specialist job is in a growing medical device company in the West of Ireland. This is a permanent job in Regulatory Affairs and requires experience in managing FDA regulatory submission process, including authoring submissions.

Responsibilities of the Senior Regulatory Affairs Specialist:
? Manages FDA regulatory submission process, including authoring submissions.
? Oversees the development of dossiers for registration of products in countries outside the U.S, including authoring submissions.
? Provides ongoing input to value improvement engineering teams on possible regulatory impact of proposed changes.
? Participate in internal quality compliance program through completing internal audits as per schedule.
? Participate in external regulatory compliance audits as scheduled.
? Monitors changes to external regulations and assesses impact to site Quality System
? Work with Global RA organization to establish RA policy and procedures
? Co-ordinate Change Notification for EU Design Dossier related to changes/transfers.
? Represent company with various regulatory bodies, such as HPRA and Irish Medical Devices Association.
? Participate and lead multi-functional and cross-site teams in areas of compliance and quality systems improvement.
? Assist in post market submissions (progress reports, annual reports etc.).
? Establish and maintain regulatory information systems both electronically and hard copy.

Education, Experience and Skills:
? Bachelor's Degree in life sciences, technical (engineering), quality or related field.
? 5 years' experience in a Quality position, with RA experience desirable. Regulatory background should include the medical device area.
? Demonstrated strong writing and communication skills.
? Strong attention to details, and ability to multitask.
? Understands the overall business environment
? Background in manufacturing with the ability to learn manufacturing processes.

For further information on this Senior RA Specialist job in Galway or any other RA jobs please contact Cliona O'Malley on 091730022 /
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