Job Title: Regulatory Specialist II (Life Cycle Management)

Role Summary

This is a strictly executional, non-management position focused on the life cycle management of medical devices. The successful candidate will manage regulatory change determinations and perform administrative updates to regulatory documentation to ensure ongoing compliance with global standards. This role does not involve people leadership or people management.

Key Responsibilities

• Regulatory Change Assessments: Evaluate modifications to devices already on the market to determine regulatory impact and follow quality system procedures to document these changes.
• Life Cycle Management: Perform mass updates across regulatory files and documentation to maintain compliance with changing regulations, such as MDR (European Union) and ISO labeling standards.
• Data Management: Utilize tools like Excel, PowerBI, and Smart Sheet to migrate, understand, and manage regulatory data across various systems.
• System Maintenance: Use the Windchill PLM system to file documentation and manage product data.
• Cross-functional Collaboration: Receive change requests from the engineering organization and collaborate with team members, primarily within the Eastern Time Zone.

What You Will Not Do

To clarify the scope, this role is specifically not involved in the following:

• Regulatory Submissions: You will not be responsible for 510ks, PMAs, or initial MDR/Europe submissions.
• Audits: Due to liability and risk, this role will not participate in active audits, though you may prepare background documentation for them.

Requirements & Qualifications

• Education: At least a Bachelor’s degree in a science field.
• Experience: A couple of years of regulatory experience is required.
• Industry Knowledge: Experience in the medical device industry is strongly preferred.
• Technical Skills: Proficiency in Excel is essential; experience with PowerBI, Smart Sheet, and Windchill is highly helpful.
• Regulatory Familiarity: Knowledge of global regulations, specifically the EU MDR (CE Mark) and technical documentation requirements, is a significant advantage.