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