Jobs for People with MS: National MS Society

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Quality Regulatory Affairs (QRA) Coordinator, Product Field Action ( PFA )

Position summary

Responsible for coordinating PFA Executions according to defined strategies, procedures and regulations. As a QRA Coordinator, PFA, 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 PFA 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 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.

• Collaborate with internal stakeholders, such as PFA process leads, site execution owners, engineers, and technicians, to ensure seamless coordination and communication regarding field action deliverables.

• Maintain a customer-centric approach by ensuring that field actions are completed promptly and meet or exceed customer expectations.

• Perform other related duties as assigned.

Education / work experience

• High school diploma plus 2+ years of relevant experience

• Coordinator or PFA experience is preferred.

• Prior project management experience is a plus.

Knowledge / competencies

• Time management skills, writing, coordination, and execution of basic regulatory items.

• Coordinate and support technical and scientific field action 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.

• Subject matter expert for the RAQA and Stryker-business requirements of their area of ownership.

• 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.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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.

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.