Description

You will manage regulatory compliance, product registrations, and quality system documentation to support product development and manufacturing.

Responsibilities

• Maintain ISO 13485 certification and prepare Technical File inputs for CE marking and international product registrations.
• Prepare and submit FDA pre-submissions and 510(k) submissions while maintaining appropriate FDA registrations.
• Review and approve Quality System documentation including Master Batch Records, SOPs, Change Orders, MRNs, and CAPAs.
• Investigate Material Review Notices (MRNs) and establish CAPAs to address root causes.
• Review product labeling, promotional literature, marketing materials, and Medical Device Reports (MDR).

Required Skills

• Bachelor of Science degree in Life Sciences.
• 5+ years of experience in a cGMP regulated facility.
• 2+ years of experience in Quality Assurance.
• Knowledge of ISO 13485, IVDR, and GMP regulations.
• Experience with CAPAs and MDR.
• Excellent proof-reading and written communication skills.
• Proficiency in computer applications.
• Must be a non-smoker to prevent product contamination.

Key Skills

Education

Bachelor's degree