Sr. Manager Regulatory Affairs

 

 

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.

 

 

 

Getinge is a global company that designs and manufactures medical devices and life science equipment. We affect the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.

 

We focus 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 to join our team.

 

We currently have an open position for a Sr. Manager, Regulatory Affairs. This position provides leadership to the Getinge organization and U.S. Field Action team to ensure compliance with all applicable Global and U.S. Field Action regulatory requirements.  Lead the process improvement activities for U.S. Field Actions team.  Serve as the primary point of contact for the ACT BA for all field action activities.

 

Primary Responsibilities

• Oversee the field action activities supporting the ACT BA related to the CD and/or similar activities with other global regulatory authorities. Provide work direction to staff members for required activities.

 

• Lead the process improvement activities for the U.S. Field Actions team.  Responsible for the planning, execution/implementation and status reporting to the Sr. Director and other members of Getinge leadership.  Serve as a member of the Community of Practice (CoP) for the Global Field Actions process area.

 

• Contribute as part of the Getinge U.S. Field Action organization, supporting all Getinge Business Areas for field actions where the U.S. is impacted and/or the BA is in the U.S., as required.  This may include timely execution of field action activities, convening and leading cross-functional team meetings for communication and awareness, ensuring timely reporting of Field Action communications to internal and external customers, coordinating the communication of follow-up letters/inquiries regarding Field Action activities with the FDA, global Health Authorities, ECRI, RASMAS/INMAR and the applicable Getinge organizations.
• Ensure monthly status reports are accurate and provided to FDA and/or Executive Management (as required) on time

• Participate and/or provide data in support of management review activities.  

• Provide input and/or be responsible for the ownership and/or updating of documents within the Quality Management System (QMS).
• 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. 
• Actively participate, as required with any external legal activities and or inspections/audits.<