Vice President of Compliance & Regulatory Affairs

Purpose:

The Vice President of Compliance and Regulatory Affairs will serve as an active member of the executive leadership team, is responsible for compliance with regulatory and legal requirements, and is responsible for development, execution of and supervision of regulatory strategies that support organizational objectives and operations that are compliant with FDA regulations, state requirements, ISO Standards, AATB Standards, and other applicable regulations.

Duties & Responsibilities:

• Define and execute regulatory strategies and solutions in support of company strategic objectives
• Hold final accountability for decision-making on the matters relating to regulatory compliance for the organization.
• Plan and oversee (or execute) all FDA, state, and other regulatory/compliance activities
• Oversee regulatory submissions for TRG letters, Request for Designation (RFD), Pre-RFD, premarket notification/approvals, 510K, unique device identifiers (UDI), state licenses, etc.
• Oversee regulatory support for validation/verification/qualification plans, protocols, execution data, and summary assessments
• Oversee regulatory review of procedures, marketing, and sales promotional label/labeling materials
• Author/revise procedures according to FDA, AATB, and other regulations (as appropriate)
• Direct, participate, and/or support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, accreditation/certification requirements, and internal policies and procedures
• Serve as principal spokesperson with customers, regulatory agencies, etc. on matters of regulatory compliance
• Direct the development of systems, practices, and processes to ensure effective ongoing review of product design and/or manufacturing changes and adverse events
• Review and implement, as appropriate and consistent with company strategic objectives, internal controls to identify, measure and manage compliance and regulatory risk
• Monitor FDA activities, to include enforcement actions, warning letters, and 483s to analyze company impact and deploy the necessary action plans
• Maintain understanding of relevant industry practices, trends, regulatory developments and legal considerations to appropriately guide the regulatory practices within the organization
• Apply knowledge of regulatory frameworks/solutions and external environments throughout the product lifecycle
• Apply knowledge of research and development, preclinical and clinical steps, and related regulations to support product development initiatives
• Provide regulatory guidance, support, and approval for new projects and products
• Provide counsel, training, and interpretation of FDA and other regulatory requirements to all company personnel
• Demonstrate knowledge of requirements and processes to maintain product on the market, including reporting and surveillance
• Develop regulatory timelines and budget forecasts and be accountable for tracking and delivering accordingly.
• Actively manage departmental resources and budget to meet strategic goals
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, cGMP/CGTP, and other organizations policies and procedures
• File and maintain records in accordance with standard operating procedures
• Manage direct reports
• Establish and monitor objective annual goals for direct reports
• Conduct performance reviews and establish performance improvement plans as needed
• Recruit, interview, and select personnel for hire
• Travel domestically and internationally up to 25% to attend offsite meetings, conferences, and support business initiatives
• Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments
• Perform other related duties as assigned
  

Skills & Abilities:

• Extensive knowledge of applicable government regulations and regulatory policies
• Ability to inform and educate department heads on regulations and policies that require compliance
• Excellent attention to detail and organizational skills
• Ability to multi-task
• Effective and verbal communication skills
• Strong Leadership skills
• Ability to secure and maintain a favorable background investigation and clearance

Education & Experience:

• Bachelor’s degree in a biological science or related field from an accredited institution required
• Master’s or Juris Doctor degree preferred
• At least 8 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field) with progressive management responsibilities/experience