Work Flexibility: Hybrid
Quality Regulatory Affairs Coordinator
Position summary
To offer a professional communication link between Stryker and our customer base for all quality support activities. Work as a liaison between customers and internal departments within the organization to ensure customer satisfaction. Responding with the appropriate action, providing answers, requested documents and replacements where appropriate.
Responsible for coordinating PFA Executions according to defined strategies, procedures and regulations. As a QRA Coordinator, responsible to oversee and coordinate all field-related activities scoped within PFA Executions. Responsible for ensuring the PFA Executions are executed in compliance with regional regulations and guidance, primarily focusing on FDA requirements. Works directly with management to ensure timely notification to regulatory agencies. Reports on a regular basis to ensure management is informed of PFA Execution status.
Serves as a member of divisional quality team to establish, implement, and maintain Global Regulatory and Quality processes and documents supporting our Global QMS.
Key areas of responsibility
- Maintain standardized process and procedure for technical support and executing field actions, including but not limited to working with international partners to ensure effective field action completion.
- Maintain PFA Execution tracking and documentation.
- Ensure that all field activities adhere to relevant regulatory requirements, industry standards, and company policies.
- Provide advice on corporate PFA Execution policies, ensuring that the Stryker Redmond and Stryker Belfast PFA Execution Procedures are current and are aligned with other Quality System Procedures.
- Develop and provide training for PFA Execution process.
- Support internal and external audit activities relating to PFA Executions.
- Communicate with regulatory agencies on the notifications and status of PFA Executions.
- Provide updates on a regular basis to management regarding status and completion of PFA Executions.
- Act as first point of contact for all technical enquiries and reported product problems.
- Maintain the Technical Support and Returns (RPA) systems and records to satisfy customer technical issues, using verbal/printed information, troubleshooting, product assessment, product upgrade and product replacement as appropriate.
- Coordinate the expedited handling/investigation of complaint issues and ensure the appropriate handling of returned products related to technical support issues.
- Develop and maintain procedures, checklists, and other document tools to support/streamline the technical support function.
- Collaborate with internal stakeholders to ensure seamless coordination and communication regarding deliverables.
- Maintain a customer-centric approach by ensuring that deliverables are completed promptly and meet or exceed customer expectations.
- Perform other related duties as assigned.
Education / work experience
- Minimum of level 3 qualification and 2+ years of relevant experience
- Coordinator or PFA experience is preferred.
Knowledge / competencies
- Time management skills, writing, coordination, and execution of basic regulatory items.
- Coordinate and support technical and scientific activities.
- Under supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility.
- Interpersonal communication, collaborative teamwork and negotiation skills. Composes routine communications with regulators and other key stakeholders
- Ability to build trusting relationships with all levels of management and clearly conveys information to peers, supervisors, and other stakeholders.
- Ability to generate and explain detailed assessments, execution plans, and any potential challenges accurately.
- Utilize proper software to maintain project records such as MS Office, TrackWise, SharePoint, or Visio.
- Seeks out diverse ideas, opinions, and insights, and applies them in the workplace.
- Connects and relates well with people who think and act differently than oneself.
- Embraces scrutiny and accepts feedback as opportunity to learn and improve.
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Travel Percentage: 10%
