United States onlyWith 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, reporting, and monitoring medical device field actions (corrections/removals). Serve as the primary representative for the organization on committees and teams for activities supporting the Cardiovascular (CS) business.
This is a defined term position for a one year term. Able to support the business during EST.
Job Responsibilities and Essential Duties
- Serve as the point of contact for the Cardiovascular field action activities. May provide work direction to junior staff members supporting field action activities.
- Work with internal and external stakeholders to plan customer notifications and required internal and external reports within strict timelines for medical device field actions (corrections/removals).
- Prepare and submit initial and monthly progress reports to regulatory authorities and internal stakeholders. Ensure related customer notifications are complete, track customer responses and product returns or servicing, as applicable, ensure related corrective and preventative actions are completed as planned, obtain updates for related complaints and vigilance reports, and confirm proper disposition/destruction of returned/quarantined affected product.
- Notify international colleagues of field actions and provide them with the documentation they need for their local/regional activities. Keep track of their progress.
- Respond to internal and external inquiries. Work with other functions (for example, Quality, Regulatory Affairs, Medical Affairs, Complaints, Customer Service, Sales Support, Service, etc.) as needed to prepare such responses.
- Support management reviews and internal/external audits and inspections with respect 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.
- 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.
- Assist with the training and mentoring of staff.
- Identify and participate in department/systems development and improvement initiatives.
- Other responsibilities as assigned.
Minimum Requirements
- A 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 and/or complaints and vigilance is preferred.
- 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.
- Proficiency with Microsoft Office Suite – MS Word, Excel, PowerPoint, Outlook, and Teams.
- 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.
Internal and External Contacts/Relationships
- Getinge Customers and Distributors
- Regulatory and Quality Functions/Departments
- Engineering/Operations Department(s)
- Marketing, Sales and Service Department(s)
- FDA and other Global Regulatory Agencies
The base salary for this position is a minimum of $130,000 and a maximum of $150,000. This is an exempt position.
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.
Sweden
