Compliance Manager

Compliance Manager

Lead a team in the divisional regulatory compliance process focused on 21 CFR Part 806. Ensure overall compliance with applicable global regulatory and statutory requirements regarding disposition of non-conforming materials distributed. Manage product containment oversight for multiple manufacturing locations in the division. Correspond with the FDA and global health authorities regarding regulatory reporting issues. Oversee correspondence among all manufacturing locations and global regulatory bodies.

Lead and facilitate CAPA process and related activities. Create CAPA's: monitor and analyze data and trending. Lead and/or support activities for process improvements and systems integration projects.

• Manage the divisional regulatory reporting process for regulatory actions to ensure overall compliance with applicable regulatory and statutory requirements.
• Lead a divisional process to ensure adequate containment of non-conforming product in all manufacturing locations. Interface with operations and distribution on quarantined product containment.
• Manage process by which senior leadership evaluates and dispositions non-conforming products in the field. Liaise with technical experts on assessments of hazards and probabilities of occurrence. Contract and manage group of medical professionals for assessment of harm severity. Compile Health Hazard Evaluations and facilitate senior management decision making regarding product disposition.
• Manage team which devises strategy for recall or repair of non-conforming product in the field. Execute regulatory actions in a timely and cost-effective manner. Work to close open regulatory actions with global health authorities.
• Oversee communications with global health authorities regarding adverse events, recalls, and other queries regarding compliance.
• Manage work team performance, including individual performance coaching and delivery of period performance feedback/reviews.
• Maintain expert knowledge of applicable Federal and foreign regulations pertaining to regulatory actions.
• Continue to assess and align the divisional processes with corporate policy, guidance, and procedures.
• Lead and participate in CAPA process and system improvements.
• Ensure CAPA activities are effectively coordinated across all plants and locations.
• Perform trending activities and maintain divisional metrics.
• Communicate CAPA data and information to management and corporate.
• Lead system integration projects in preparation for eTrackwise implementation.
• Actively promote a team approach to the CAPA process across all departments and Spine plants

Qualifications/Work Experience

• 5 years regulatory reporting experience in medical device or other regulated manufacturing environment
• 5 years experience in developing and implementing quality management systems
• Applied understanding of QSR (21 CFR Part 820), Medical Device Reporting (21 CFR Part 806), Enforcement Policy (21 CFR Part 7), ISO 13485, European Medical Device Directive, and Canadian Medical Device Regulations (CMDR)
• Demonstrated ability to work effectively with a variety of work groups, including multi-national teams, to assure conformance to regulatory requirements, internal processes and procedures
• Demonstrated ability to lead a team of individual contributors
• Demonstrated ability to achieve objectives with minimal supervision
• Demonstrated ability to effectively prioritize tasks in a deadline-driven environment
• Demonstrated ability to manage complex projects
• Demonstrated written, verbal and organizational skills
• Demonstrated PC proficiency in relevant Microsoft Office Suite applications (Outlook, Word, Excel, Power Point).

Education and/or Special Training

Bachelor's Degree in a scientific discipline or other relevant field of study; prefer Master's Degree or equivalent additional coursework.

Percent Travel Required

10-20%