Getinge is a global company that designs and manufactures medical devices and life science equipment. We impact the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.
We are focused on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team.
We currently have an opening for a Regulatory Affairs Specialist who will provide support in the Field Action team in Regulatory Affairs. This position will ensure compliance with all applicable regulatory requirements with specific focus on field action compliance.
Primary Job Functions:
- Responsible for U.S. Field Action; corrections and removals including preparation of Monthly Status Reports and tracking Effectiveness Checks.
- Coordinate submission activities and internal and external communications for U.S. field action activities.
- Assist in Medical Device Licensing, Establishment Registrations, Device Listings (50 States), as needed.
- Helps coordinate all procedures, training and systems to ensure compliance to U.S. regulatory processes for all GETINGE products distributed in the U.S. with emphasis on field action compliance.
- With supervision, develop and maintain positive relationships with U.S. FDA regulatory agency thorough oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review and field action requirements.
- Coordinate submission activities for all GETINGE U.S. field actions. With oversight and as needed review device labeling and advertising materials for compliance submissions and applicable regulations; analyze and recommend appropriate changes.
- Support internal and external audit activities.
- Participate in department/systems development initiatives.
- This is not an inclusive list of job responsibilities
Required Knowledge, Skills and Abilities:
- A Bachelor's degree in a scientific or technical discipline is required or equivalent work experience.
- A minimum of three years US FDA Medical Device Regulatory Affairs experience including conducting Medical Device Field Actions, or equivalent work experience is required.
- Must have general understanding of product development process and design control.
- Must be able to manage several projects simultaneously.
- Proficiency with Microsoft Office Products such as Word, Excell, and PowerPoint or equivalent software applications is preferred.
- Must demonstrate effective research and analytical skills.
- Must demonstrate effective written and verbal communication, including technical writing skills.
- Must be able to work independently with minimal supervision.
We look forward to receiving your application.
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