Integra LifeSciences

Auditor

• Lead, coordinate and perform corporate audits of the Quality Management System (QMS) as part of Integra LifeScience’s quality internal audit program.
• Ensure that the corporate audit policy/procedures are fully implemented on audits conducted.
• Work alone or lead a multi-skilled team of auditors.
• Perform audits in compliance with recognized ISO, GMP, GDP, GCP, and GLP policies/procedures.
• Physically perform and be responsible for the audits assigned as part of the annual corporate audit schedule.
• Provide internal consultancy on specific area of expertise to the audit team and assist with improving audit standards and inspection readiness.
• Supply formal reports to the head of the audit program on site audits, including audit observations and recommendations.
• Identify problematic areas of site and quality system operations during audits and assist with improvement.

Lead Auditor, Quality Compliance

Compliance

• Implementing regulatory strategies for the Company with a focus on achieving compliance for all current and upcoming regulations in the US, EU, Canada and globally
• Providing regulatory input for regulatory documentation and development or sustaining projects to ensure that regulatory requirements are met
• Analysis and review of data
• Resolution of regulatory issues of moderate scope
• Maintenance/update of existing technical files
• Ensuring that new products are compliant to new requirements
• Utilizing an intermediate base of knowledge and understanding of regulatory requirements, documentation, language, and the submission filing process to support a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for the business
• Provide regulatory input to cross-functional teams
• Works mostly independently to evaluate regulatory issues, contribute to, and implement regulatory strategies, and revise technical documentation for existing and new regulatory submissions
• Aid Supervisor in the development of US and International regulatory strategies and verification and validation activities for assigned product submissions
• Author draft submissions (including MDR Technical Documentation) under supervision
• Ensure timeliness of regulatory submissions according to business needs
• Includes ensuring prompt follow-up to the questions and requests received from regulators
• Assist with the coordination, preparation, and maintenance of FDA PMA and BLA filings such as Annual Reports, 30 Day Notices, and 180 Day Submissions in accordance with US FDA requirements
• Begin to interact with Regulatory Body personnel under direct supervision
• Actively assist with upcoming audits and certification reviews with all Company designated Notified Bodies
• Support communication with the Company’s Notified Bodies regarding regulatory issues/questions and schedule Technical Documentation/Technical File reviews
• Maintain Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements
• Review promotional and advertising material for adherence to approved product claims and regulatory compliance
• Work in partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with US, Canadian, European, and International regulations
• Coordinate rollouts of product changes with corporate and international regulatory teams
• Coordinate Unique Device Identification system requirements and other labeling compliance of new products introduced into the market
• Work with cross-functional management to review and approve rework of non-conforming product CAPA, SCAR, HHE and Field Actions
• Support product risk management in accordance with FDA/ISO 14971 under supervision
• Review basic Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations
• Works under moderate supervision
• Review labeling that requires regulatory review and approval to ensure compliance with government regulations
• Apply company policies and procedures to resolve a variety of issues of moderate complexity; Provide solutions to a variety of problems of moderate scope and complexity
• Participate in continuous improvement projects within Regulatory Affairs and throughout the organization, as assigned
• Contribute to the authoring of SOPs
• Perform other duties as assigned

Lead Auditor, Quality Compliance

Regulatory Affairs Specialist