Program Manager, Field Actions Planning (NJ/NY)

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Job Overview

 

Responsible for planning, coordination, and reporting medical device field actions (corrections/removals) in collaboration with business area partners in compliance with global regulatory requirements.  This position requires close collaboration with cross-functional business partners to ensure the timely and effective execution of field actions to maintain regulatory compliance.

 

Job Responsibilities and Essential Duties

• Collaborate effectively with all Business Areas across Getinge and serve as subject matter expert (policies, regulations, compliance, actions, strategies) for US FDA regulations for Corrections and Removals and the Getinge US Field Action process. 
• Work with internal and external stakeholders to plan and initiate field actions, including required internal and external reports within required timelines for medical device field actions (corrections/removals) for all Getinge entities.  
• Communication with Business and/or Product Area leadership and their teams regarding field action status and other related topics to field actions.
• Coordinate with cross-functional teams to ensure all documentation, reporting, and communication related to field actions are accurate, timely, and comply with regulatory guidelines.
• Facilitate preparation and submission of initial reporting to global regulatory authorities and internal stakeholders.
• Maintain comprehensive records of all field actions, ensuring documentation is complete and accessible for internal and external audits.
• Facilitate meetings with and/or notify global colleagues of field actions and provide required documentation for local/regional activities.
• Lead the process improvement activities for Planning activities for the U.S. Field Actions team. 
• Collaborate effectively with all BAs across Getinge and serve as subject matter expert (policies, regulations, compliance, actions, strategies) for US FDA regulations for Corrections and Removals and the Getinge US Field Action process. 
• Responsible for facilitating responses and responding to internal and external inquiries.  Work with other functions (for example, Quality, Regulatory Affairs, Medical Affairs, Complaints, Customer Service, Sales Support, Service, etc.) to prepare such responses.
• Support management reviews and internal/external audits and inspections concerning field actions  by providing regular updates and reports on the status of field actions, regulatory submissions, and any compliance risks.
• Provide input for and/or review departmental procedures, work instructions, templates, and guidance.
• Develop and maintain positive relationships with U.S. FDA, EU Notified Body, and global regulatory agencies through oral and written communications related to field actions.
• Stay current on changes to global regulatory requirements and industry standards related to medical device field actions, incorporating new guidelines into the company’s processes.
• Other responsibilities as assigned.

 

Required Knowledge, Skills and Abilities:

 

• Bachelor’s Degree or equivalent combination of education and relevant experience