Director, Global Patient Safety Operations

As a Director in the Health Compliance Organization (HCO), you will work with the Patient Safety team, Regulatory, Legal, and the Chief Health and Life Science Compliance Officer as well as our internal business groups to ensure efficient and compliant complaint handling, patient safety, and vigilance reporting operations. As the process owner of SOPs covering global cross-functional patient safety and quality technical complaints for medical devices (SaMD), you will lead a team to build new and efficient approaches to facilitating compliant complaint handling and MDR vigilance reporting. The Director of Global Patient Safety Operations is responsible for overseeing the global device vigilance areas of case evaluation and reporting, quality and compliance operations ensuring effective operations and compliance across our portfolio and geographies.

This senior level role requires a strategic business leader with experience in leading operations teams, proven abilities with team development, in depth understanding of medical device (SaMD) vigilance operations, quality and compliance, planning, and assessing and implementing regulatory requirements, along with shown capabilities to lead cross-functional initiatives. The Director of Global Patient Safety Operations will drive operational excellence, compliance, and continuous improvement of globalization and innovation of device vigilance capabilities, operations, and compliance. This leader will develop a high-performing team, provide team oversight of talent development, and be part of the HCO Leadership Team.

Preferred Qualifications:

• BA/BS degree and minimum of 10 years of experience, including leadership responsibility, in patient safety, regulatory or vigilance operations at a medical device or healthcare information technology company. 
• Experience with leading quality, regulatory or vigilance compliance operations involving software as medical device (SaMD) regulations.
• Excellent skills with Email, MS Word, Excel, Powerpoint and Oracle systems. 
• Possess a professional demeanor, confident and innovative.
• Knowledge of Oracle policies, contracts and procedures.
• Excellent writing, analysis, verbal communication skills and read, write, and speak the following languages: English.
• Organized, detail oriented, and strong time management skills.
• Problem solver (not just an issue spotter) with creative and innovative approach along with strong decision-making abilities.
• Outstanding project management and communication skills.
• Ability to perform in a fast-paced and continually evolving business environment.

Career Level - M4

• Work closely with the Person Responsible for Regulatory Compliance (PRRC) as medical device vigilance SME in global multidisciplinary projects in gap assessment, development, implementation and maintenance of procedures and processes to ensure compliance with ISO 13485, Regulation (EU) 2017/745, US FDA Medical Devices and other global device regulations; gap assessment of medical device vigilance, technical complaint and safety event handling procedures and processes.
• Lead implementation, management and maintenance of medical device vigilance systems and SOPs that are compliant with local and global regulatory requirements, QMS and corporate standards. 
• Lead a team of Quality and Patient Safety professionals responsible for owning, processing, and adjudicating technical reports involving safety concerns; build an efficient organization and processes for managing these activities.
• Support complaints investigation, MDR reporting and Quality Management remediation efforts while ensuring compliance is met with applicable regulations and relevant Quality Management System procedures for the remediation of both reportable and non-reportable complaint investigation files. 
• Work closely with regulatory team to support drafting and submission of required notifications to global regulatory authorities.
• In collaboration with functional Quality and Regulatory leads, be responsible for the discovery, evaluation, and potential implementation of safety function regulatory requirements. Proactively monitor and interpret the external global regulatory environment for regulatory issues, trends, and changes that have the potential to impact our products. 
• Serve as an operational leader within the Healthcare Compliance Organization setting the bar by demonstrated behavior and outcomes.��
• Support developing updated and new policies and standard operating procedures.
• Support and manage compliance governance processes through multiple cross-functional governance forums such as patient safety, quality and Executive Health Board.
• Support the onboarding, training and group activities of the team.
• Assist with team updates and preparation of presentation and tr