Remote Program Manager, Medical Device Field Actions (NJ)

Getinge; Wayne (NJ); Remote; USD 144,000 - 150,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Wellness initiative & Health Resources

Life Insurance

Disability Benefits

Flexible Spending Accounts

Commuter Benefits

Parental and Caregiver Leave

Tuition Reimbursement

Job summary

Getinge is seeking a field actions regulatory specialist in the United States to manage planning, coordination, and reporting of corrections and removals in line with global regulatory requirements.

The role requires collaboration across business areas to ensure timely execution and comprehensive documentation, with a defined two‑year term. Strong knowledge of FDA guidelines and post‑market activities is essential.

Qualifications

• Bachelor's degree in a scientific or technical discipline or equivalent work experience. Advanced degree preferred.
• Minimum 6 years of experience with medical devices or pharmaceuticals in a Quality, Regulatory Affairs, or Regulatory Compliance role.
• Three or more years prior experience with field actions or leading post market quality projects.
• Program Management experience in Quality function.
• Advanced knowledge of Quality Management System operations and application of Regulations, ISO standards, and management controls.
• Experience with post‑market quality activities - recalls/field actions, CAPA, complaint handling, corrections and removals.
• Experience with FDA and/or Notified Body audits/inspections.
• Excellent time management skills, ability to work independently, self‑motivated, and highly accountable for deliverables and timelines.
• Detail‑oriented, highly organized, and performs work with a high degree of accuracy.
• Proficiency with Microsoft Office Suite - MS Word, Excel, PowerPoint, Outlook, and Teams.

Responsibilities

• 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 Global Field Action process.
• 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 process improvement activities for Planning activities for the U.S. Field Actions team.
• 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. This may involve participation as subject matter expert in the audit/inspection front room.
• 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.

Skills

Regulatory affairs

Quality management

FDA inspections

Post-market actions

Project management

Documentation control

Stakeholder communication

MS Office

Education

Bachelor's degree

Tools

MS Word

Excel

PowerPoint

Teams

Job description

Getinge is seeking a field actions regulatory specialist in the United States to manage planning, coordination, and reporting of corrections and removals in line with global regulatory requirements.

The role requires collaboration across business areas to ensure timely execution and comprehensive documentation, with a defined two‑year term. Strong knowledge of FDA guidelines and post‑market activities is essential.