Program Manager Field Action Execution

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 monitoring, tracking, and reporting of medical device field actions (corrections/ removals) in collaboration with business area partners in compliance with global regulatory requirements.   This position ensures that all field actions are managed in compliance with global regulatory requirements, and that accurate and timely reports are prepared for submission to  regulatory authorities

Job Responsibilities and Essential Duties

• 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 as well as the Getinge US Field Action process. 
• Work with internal and external stakeholders to monitor and report on initiated field actions, including required internal and external reports within required timelines for medical device field actions (corrections/removals) for all Getinge entities.  
• Collaborate with internal teams, including regulatory, quality, manufacturing, and customer service, to gather data and ensure all aspects of field actions are accurately tracked and documented.
• Provide ongoing status information to Business and/or Product Area leadership, and their teams, including escalation notifications regarding potential timeliness concerns. 
• Facilitate preparation and submission of required ongoing reporting to global regulatory authorities as well as internal stakeholders.
• Lead the process improvement activities for Execution 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. 
• Ensure that field actions are appropriately documented in regulatory submissions, audits, and post-market surveillance activities.
• As requested, provide input/feedback for any global regulatory inquiry.  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.
• Train internal teams on regulatory expectations, reporting processes, and best practices for field action management.
• 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 best practices related to medical device field actions, incorporating these into the company’s processes and procedures.

Minimum Requirements

• Bachelor’s Degree or equivalent combination of education and relevant experience
• A minimum of 7 years of relevant industry experience
• Advanced Degree highly preferred
• Advanced knowledge of Quality Management System operations and application of the Regulations, ISO standards, and management controls.
• Proven experience with post-market quality activities – recalls/field actions, CAPA, complaint handling, corrections, and removals.

Required Knowledge, Skills, and Abilities

• Advanced knowledge of Quality Management System operations and application of the Regulations, ISO standards, and management controls.
• Experience with FDA and/or Notified Body audits/inspections.
• Exceptional verbal, written, and presentation skills.
• Excellent time management skills, ability to work independently, self-motivated, highly accountable for deliverables and timelines.
• Detail-oriented, highly organized, and performs work with a high degree of accuracy.
• Effective problem-solving capabilities, solution-oriented with the ability to understand, review, and communicate complex technical concepts concisely and accurately.
• Promotes successful teamwork and morale.
• Proficiency with Microsoft Office Suite – MS Word, Excel, PowerPoint, Outlook, and Teams.

salary  min 124,000 - 165,000 plus 15%

About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.