Regulatory Affairs Specialist III

Overview

Position Summary:

This position is responsible to ensure 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

Essential Functions:

• 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

Secondary Functions:

• 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

Budget Managed (if applicable)

• N/A

Internal 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

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and 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.

Competencies:

• Attention to Detail: Ability to pay close attention to detail is required
• Accuracy: Work is accurate and complete
• Performance Standards: Demonstrated ability to meet department goals
• Communication: Excellent written, verbal and presentation skills
• Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality
• Multi-Tasking: Ability to manage multiple priorities, and support changing business needs
• Collaboration: Ability to work within a team to bring best solutions to the team or customer
• Independence: self-motivated-works under minimal supervision
• Professionalism: Must demonstrate professionalism during all interactions within
• company, customer and third  parties
• Takes Initiative: Serves as a role model for "Quality First" by continuously improving on what matters most to customers
• Problem Solving: Promptly and effectively handles issues and problems
• Decision Making: Makes decisions based on data and risk determination

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

Additional Skills/Knowledge:

• 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 and international country regulations
• Knowledge of design control requirements and understanding of GMP
• Language: English

International Mobility:

• Required: No

Travel Requirements:

• <10% of time