Job Title: Senior Regulatory Affairs Specialist

Job Location: Scotland

Job Type: Permanent

Salary: Competitive

Responsibilities:
Preparation of regulatory documentation and submissions for product approvals
Development of regulatory plans/strategies for new products and changes to existing products
Participation in Design Control, Risk Management and Post Market Surveillance activities
Production and review of design dossiers, technical files and change assessments
Review and preparation of regulatory paperwork in accordance with International standards and new regulations
Review Custom Made Device Technical File, and sign the Statement of Compliance on behalf of and in the absence/unavailability of Principal, Regulatory and Scientific Affairs
Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations

Essentials:

BSc Hons Degree
Regulatory experience within a me...

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