The Director, Post Market Safety (PMS) is a Global Process Owner (GPO) and leads hub and spoke teams to establish, implement, and maintain Global Post Market Regulatory and Quality processes, tools and documents supporting our Global QMS.
The primary global processes in the PMS space include, but are not limited to, Nonconformance, Commercial Hold, Corrective and Preventive Action, Product Field Action, Complaints, Service, Post Market Reporting, Adverse Event Reporting, and Divisional Post Market Account Manager. The areas of responsibility for PMS process may be shared by multiple GPOs and divided by process, business segment, geography, and/or volume/workloads. While each GPO shall be fully capable of owning any aspect within the PMS space, overall accountability for each process will be assigned to a single owner.
The GPO is responsible for developing global strategies for PMS systems to ensure process compliance, effectiveness, and efficiency, including driving continuous improvement. This person possesses and applies institutional knowledge in a strategic and innovative manner and has achieved recognized standing in a related professional field through contribution to the organization and/or diverse external groups. The GPO advocates for Stryker's needs internally and externally, which may include representing Stryker in industry forums and/or programs (e.g. AdvaMed, MDIC) and liaising with internal colleagues (e.g. Government Affairs and Market Access, RAQAC Legal, and Global Quality, Regulatory, Clinical leadership).
The GPO directs the Corporate Product Field Action Board (PFAB) to assess and approve Product Field Action Assessments (PFAAs) across Stryker, including materials for executive leadership (SLT/OST & BOD). The GPO directly interacts with VP-level professionals at the Divisions to provide feedback on PFAAs submitted to the Corporate PFAB.
To successfully perform the role, the Director, Post Market Safety shall:
Collaborate with GPO & eSystem peers to ensure alignment, synergy, and efficiency with related processes.
Possess extensive knowledge and experience within TrackWise.
Serve as primary point of contact for their assigned processes, businesses, and/or geographies.
Partner with peer PMS GPOs to ensure internal customer needs are met.
Evaluate PFAAs as a member of the Corporate PFAB to ensure records:
Are complete (can stand alone), accurate, complaint to company policies and precedents, and evaluated in a timely manner
Note: Will not evaluate PFAAs from their assigned areas of responsibility to maintain independence
Partner with PFA Division Process Owners on PFAAs prior to Global PFAB submission to:
Ensure timely processing of PFAA records
Provide objective input on completeness and accuracy of the record
Liaise with key teams across the business to facilitate collaboration, ensuring key perspectives are included, relevant company precedents are considered, and provide actionable, timely feedback from the Global PFA Board.
Essential Duties & Responsibilities: (Detailed Description)
Coordinates division and adjacent GPO input and represents collective needs.
Owns global documents and training materials and is the business owner of related eSystems.
Updates Global Governance, RA/QA Leadership and PMO on direction and progress.
Ensures global initiatives are communicated and understood by stakeholders.
Serves as the voice of the Global Processes in the PMS space for Stryker.
Travels to and leads hub and spoke meetings.
Leads meetings, surveys, information-gathering and global decisions for geographically dispersed teams.
Delivers against agreed project deadlines and reconciles implemented sites.
Communicates to leadership and stakeholders at a global level.
Leads global cultural change.
Govern over Nonconformance, Commercial Hold, Corrective and Prevent Action, Product Field Action, Complaints, Service, Post Market Reporting, and Adverse Event Reporting systems
Responsible for strategic direction of global PMS processes
Lead the Company in developing and updating associated procedures to ensure alignment and compliance to regulatory expectations with regard to PMS processes.
Develop and disseminate associated PMS training to Sites, Divisions, and HCPs, as appropriate.
Establish key quality metrics/targets and help drive company-wide improvement across PMS processes.
Review and approve product field action assessments for the Corporation as defined within the product field action process.
Direct the company-wide efforts related to input systems for PMS processes to assure compliant and effective monitoring, trending and reporting systems are in place.
Assist in developing tools to provide metrics and trends to improve timeliness and efficiency of the processes.
Act as SME and mentor for PMS processes throughout Stryker
Responsible to effectively communicate and escalate issues regarding Site and Division Post Market Safety performance to the appropriate Division or Corporate level.
Perform other related duties and special projects as assigned.
Recognized as thought leader in advocacy activities
Influences changing regulations and guidance
Education & Special Trainings:
BS in Engineering, Science, or related Advanced degree preferred, or MS in Regulatory Science
Typically a minimum of 15 years experience
RAC(s) desired
Prior cross-site/division experience desired
Qualifications & Experience:
Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and
International requirements.
Demonstrate technical knowledge of medical device product lines.
Demonstrated written, verbal, listening, communication, and team-building skills.
Demonstrated ability to collaborate effectively with and lead cross-functional teams.
Demonstrated ability to effectively prioritize and manage multiple project workloads.
Demonstrated experience with trending and analysis reporting.
Demonstrated leadership skills.
Demonstrated process improvement and management skills.
Experience with recruiting, people development.
Influence across the organization.
Wins support and buy-in from sponsors, partners, and stakeholders by effectively satisfying stakeholder interests and concerns while advocating a clear direction forward; and coaches others to do the same
Models, encourages, and creates the conditions of an inclusive and respectful work environment; acts as a catalyst and change agenda for creating an inclusive and respectful work environment
Models humility by readily taking responsibility for errors, acknowledging opportunities for improvement, pursuing new ideas and perspectives and applying learning
Actively engages in talent management practices (selection, promotion, development, and engagement) to cultivate a workforce that is well aligned with current and emerging talent needs
Builds and sustains partnership across organizational boundaries and functions as well a outside the organization to achieve common goals and outcomes
Leads thorough analysis of situations with appropriate attention to details and the big picture including consideration of impact at multiple levels of the system
Makes timely and effective decisions, balancing the need for more information or analysis with the need to be decisive
Makes tough or unpopular decisions where mission outcomes supersede the interests/concerns of individuals, constituencies, or current situation
Factors cultural considerations and impact into decision-making
Actively leads and engages in policy development, implementation, and communication by framing emerging issues and contributing expertise in support of the organization's vision, strategy, priorities, and obligations
Ensures knowledge and lessons learned are shared across organizational boundaries
Effective communicator and consensus-builder
Proven ability to implement large-scale projects across geographies or businesses
Developed and monitors metrics which drive positive change for the business and culture
Physical & Mental Requirements:
May involve prolonged periods of stooping, kneeling, crouching, bending, sitting, standing, and/or crawling as appropriate.
May be required to move equipment up to 50 pounds, reach, push, or pull in order to accomplish job accountabilities.
Coordination of eye, hand, and/or foot movement with an ability to grasp by hand and meet cognitive demands to include visual and auditory discrimination/memory, reading ability, and memory retention ability.
Must be able to analyze and resolve issues of moderate scope using independent judgment.
Must be able to prioritize work and keep detailed records.
Must be able to communicate with large groups of people.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
