Job OverviewResponsible 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.
This position is for a defined term position with Getinge of two years.
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 and the Getinge Global 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 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.
Required Knowledge, Skills and Abilities- Bachelor's degree in a scientific or technical discipline or equivalent work experience. Advanced degree preferred.
- A minimum of 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.
- Exceptional verbal, written, and presentation skills.
- 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.
- 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.
The base salary for this position is a minimum of $144,000.00 and a maximum of $150,000.00.
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Benefits at Getinge:At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
