Director of Regulatory Affairs

The ideal candidate is an expert in Medical Device packaging, regulatory and sterilization.

Responsibilities

• Act as the technical expert for all medical device regulations (FDA, CE, ISO, etc.) ensuring the proper processes, policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance
• Augment OEM sales efforts by connecting with prospective clients as an expert in sterilization, packaging and regulatory matters
• Maintain compliance with current industry standards as well as state and federal regulatory requirements
• Connect and consult with prospective clients as an expert in sterilization, packaging and regulatory matters
• Assure engineering design processes and manufacturing processes are conducted in compliance with the QMS
• Manage internal quality team
• Evaluate and develop process improvements for product issues and to improve overall quality of product and processes
• Educate/train company employees on regulatory matters to assure compliance with requirements

Qualifications

• 5 or more years’ experience in some combination of medical device Regulatory and Quality roles.
• 5 or more years’ experience medical device sterilization and packaging validations.
• Extensive knowledge of FDA (including GMP), Medical Device Regulation (MDR) and ISO regulations as it relates to medical devices, inspections, filing and approvals.
• Adaptability and resourcefulness to roll‐up‐sleeves and multi‐task in order to thrive in small company environment