Specialist III, Regulatory Affairs

Overview

Job Summary

This position is responsible to ensure pre-market and/or post-market regulatory activities are in compliance with domestic and international regulations. Working independently, with guidance from manager or more senior staff, the position will participate in team meetings, prepare submission and registration documentation, assess and document device changes, prepare field notifications and vigilance reports, and prepare post-market documentation. This is a technically focused role, requiring advanced skills in analyzing information, reviewing test protocols and reports, preparing regulatory documentation, and promoting regulatory compliance.

Responsibilities

Key Accountabilities

Post-Market:

• Advise and direct teams on regulatory requirements for on-market product changes
• Author regulatory determinations as regulatory lead for on-market product changes, including interfacing with country market approval holders to confirm local regulatory requirements
• Ensure company site and device registrations are compliant with applicable domestic and international regulations
• Ensure global compliance of post-market surveillance program
• Author documentation and regulatory strategy in support of global field corrective actions/ recalls and vigilance reports
• Review and approve changes orders for product labeling changes, regulatory procedure changes and marketing communications as required
• General:
• Increase working knowledge of regulations, standards, company SOPs and tools
• Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management
• Assist in tracking standards, regulations and all applicable requirements
• Other duties as assigned
• Assesses regulatory gaps and take the appropriate corrective actions, as needed
• Supports internal and external audit as required
• Participates in regulatory improvement projects as required

Networking/Key relationships

To be determined based on department needs, to include interactions such as:

• Work closely with other functions and across facilities to generate regulatory documentation in alignment with domestic and international requirements
• Ability to negotiate and influence others in establishing direction toward improved regulatory and enhanced compliance
• Ability to effectively communicate regulatory requirements to a broad population of constituents

Qualifications

Minimum Knowledge & Experience required for the position:

• Education: Bachelor’s degree or higher, preferably in science and/or regulatory
• Experience: Minimum of 5-years’ experience in medical devices, in vitro diagnostics, pharmaceuticals or clinical laboratory or 2 years’ experience with an advanced degree

Skills & Capabilities:

• Ability to read and interpret domestic and international regulatory/quality standards related to our products
• Working knowledge of IL products, technology, and regulatory requirements, including impact on customers and patient requirements
• Demonstrates judgment commensurate with experience regarding application of regulatory requirements to data review, protocols, reports, design changes, etc. to ensure compliance and achieve business objectives
• Recognition of when to escalate issues to management or consult with more senior staff members.
• Duties necessitate broad and thorough knowledge of regulatory and compliance requirements, including domestic and international regulations
• Understanding of the application of regulatory principles in the areas of pre-market or post-market compliance
• Knowledge of FDA, ISO, MDSAP, IVDR, MDR and international country regulations
• Knowledge of design control requirements and understanding of GMP
• Language: English

Travel requirements:

< 10% of time