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Sr. Director, Data Analytics and Risk ManagementProvide strategic and groundbreaking direction for the Post-Market Surveillance process within Philips Global E2E Risk Management Framework as part of the Philips Quality Management System.Your role:This role will lead risk management processes and execution throughout Philips landscape directly contributing to the improvement of product quality and patient safety. Additionally, this leader will manage the Global PMS data analytics center of excellence, clinical evaluation and regulatory inquiry teams providing services and executing operational activities on behalf of B/R/FLead the Data Analytics Organization:
Support senior leadership by providing data insights to drive top and bottom-line performance and company performance
Build the platform to drive efficiencies and consistency in providing data insights by consolidating data for an enterprise view
Ensure that Risk Management, Post-Market Surveillance and Complaint Handling are well-integrated within the Philips Quality & Regulatory domain:
Ensure a comprehensive and compliant risk management process is defined, deployed and maintained in Aris for the Philips organization
Develop training on risk management fundamentals and specific critical skills and deploy to the business as required.
Maintain a Center of Excellence and Community of Practice for risk management to promote central process governance, continuous process improvements, and skills development.
Drive development of risk management Philips Integrated Landscape (PIL) solution.
Manage the identified needs of the businesses for localizations with respect to deployment and adoption of the ARIS PEPF risk management process.
Manage central team support for both deployment and remediation activities at the businesses
Lead and transform Philips Risk Management within Philips Quality Systems.
Support ongoing integration with Pre-Market Risk Management and Complaint Handling
Oversee Clinical Operations as part of Global Complaint Management organization:
Manage Clinical Reportability Assessment, using clinical subject matter expertise, to complete assessment of events for reportable death or serious injury.
Manage Clinical Harm Review, including an assessment of reported event severity, causality, and a determination as to whether the reported event is described in product labeling/risk management file documents.
Serve as subject matter authority and enforce all relevant compliance and regulatory standards affecting Medical Device.
Partner with global and cross-functional teams in resolving patient issues and developing continuous process improvement initiatives.
Evaluate efficiency of relevant post-market quality systems to resolve gaps or areas for improvement; convey results of assessments with appropriate actions to executive management.
Monitor and ensure timeliness of all complaint’s process and reporting activities in accordance to procedures, standards and regulations.
Manage Documents assessment and/or harm review in QCM TrackWise Complaint Handling tool or other complaint database.
Facilitate and communicate the escalation of complaints for further investigation/decision making based upon established PEPF criteria (IIA, HHE, CAPA).
Manage Regulatory Inquiry team as part of Global Complaint Management organization:
Enforce standardized and simplified regulator inquiry response practices.
Provide leadership and subject matter expertise to a team of Vigilance Reporting Specialists who are responsible for developing responses to inquiries from regulators related to worldwide adverse event report submissions.
Introduce and implement processes and tools required to ensure global regulatory compliance, quality, and patient safety.
Manage compliance to FDA regulations and other Regulatory Agencies.
Manage the oversight and review of regulatory inquiry responses globally.
Actively participate in inspections and questions relating to the operation of complaint handling operations, processes, and procedures in coordination with all other applicable company groups.
Prepare and execute the global Quality policy, by initiation and coordination of related activities throughout all disciplines in order to make the Philips a top-tier company in safety and compliance.
Develop organizational policies and authorizes their implementation.
Provide direction to senior managers in various areas, groups, and/or operations.
Perform independent technical assessments on audit findings related to businesses, provide feedback and confirm that the central risk management process adequately addresses the identified issue(s)
Key performance indicator (KPI) leader for the Global Post Market Surveillance Group.
Support external audit finding action items related to central risk management process.
Create and deploy a single aligned strategy in Quality and Regulatory Compliance
Ensure timeliness of regulator inquiry responses.
Ensure no-major non-compliances in applicable process/records.
You're the right fit if:
12+ years experience, with at least 6 years in FDA medical device environment, and a Bachelor’s degree; or a Masters and a minimum 10 years or a PhD with minimum 8 years’ experience. (Complimentary experience in R&D and Operations is preferred in addition to quality and regulatory experience)
5+ years experience in clinical experience
Proven group/site level leadership and management experience in various aspects of Q&R (including internal and external representation on Q&R)
Confirmed experience establishing global Q&R strategy & oversight, QMS etc., at business/manufacturing site level in a global company.
Advanced understanding, experience, and leading tasks in risk management, Post Market Surveillance and Complaint Handling.
Working in remediation/transformation environments is required because this individual/leader will deliver on continuous improvements across various quality and non-quality type processes.
Successfully executed FDA and/or other regulatory audits/inspections is required.
Previous experience with corresponding to inquiries associated with regulatory device reporting (i.e. MDR, MDV, etc.) is required
Must have direct experience/knowledge of most regulations relative to PMS activities and reporting, such as: ISO 9001/13485/14971, FDA Regulations (21CFR (803, 806, 82, etc.)), CMDR, JPAL, Medical Devices Directive (93/42/eec, 98/79/EC)), and EU MDR is preferred.
Demonstrates collaborative customer focus; with high performance behavior of shared accountability, listening and learning, sense of urgency, trust and influence management, self-growth, empowerment, and continuous improvement.
Willing to travel 25% globally. International travel typically required to support strategic and key initiatives and leadership activities.
About PhilipsWe are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business (https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Read more about our employee benefits (https://www.careers.philips.com/na/en/best-employee-benefits) .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here (https://www.careers.philips.com/global/en/diversity-and-inclusion) .Philips Transparency DetailsThe pay range for this position is $175,000 to $300,000, annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here (https://www.careers.philips.com/na/en/best-employee-benefits) .At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.Additional InformationUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran
