Manager Regulatory Affairs - Regulatory Information Management (RIM) System (Remote US)

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 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 1.5C 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 Manager Regulatory Affairs who will oversee the implementation and day-to-day utilization of a new global Regulatory Information Management (RIM) System for Getinge's medical device businesses within the Acute Care Therapies and Surgical Workflows business areas and Getinge's global Sales and Service Units. This position will be the primary interface between the Getinge global Regulatory teams and the RIM software provider and will provide strategic guidance and technical expertise to ensure that the RIM System is configured to meet internal stakeholder needs and internal utilization is consistent, reliable, and effective across Getinge teams. Getinge has selected the Rimsys platform as our RIM solution.

This position may be based at any Getinge location, with a preference for locations in Europe or United States (East Coast time zone only).

Remote locations may be considered for the right candidate if based in a time zone that can virtually support a majority of the Getinge business locations.

Job Responsibilities:

• Responsible for leading the implementation and maintenance of a new RIM System across Getinge by working collaboratively across Getinge's Acute Care Therapy, Surgical Workflows, and Sales and Service Unit Regulatory teams and other internal and external stakeholders.
• Act as the primary interface between Getinge Regulatory Affairs and the RIM Service provider.
• Lead initial RIM configuration and drive future configuration improvements between Regulatory stakeholders and RIM service provider.
• Develop process maps, workflows, procedures, and work-instructions to harmonize and facilitate use of the Rim System.
• Responsible for daily administration of the Regulatory Information Management System (RimSys), including (but not limited to) user management, training, issue escalation and resolution.
• Develop and implement robust data governance model.
• Continual evaluation of data integrity, accuracy, and consistency.
• Develop, maintain, and communicate Regulatory reporting and metrics from the RIM system.
• Prepare for future phased implementation of additional RIM modules and functionality, including standards management, UDI, and EUDAMED.
• Conduct periodic audits of regulatory data and product portfolio to ensure ongoing compliance.
• Collaboration with RIM Vendor, Getinge IT, and Getinge Procurement to maintain the license and contracts on behalf of Getinge

Qualifications, Background and Experience :

• Bachelor's Degree is required. Advanced degree is preferred.
• Minimum of 6 years medical device regulatory experience is required.
• Strong knowledge of global Regulatory processes, including typical interactions between business regulatory teams and country regulatory teams, is required.
• Solid inter-personal skills and ability to build connections remotely via Teams video calls is required.
• Willingness to adjust personal work schedule to accommodate various time zones for training or issue resolution in support of the Getinge global regulatory affairs organization is required.
• Strong presentation skills and ability to communicate new information clearly and succinctly to a global audience is required.
• Prior experience implementing or using a Regulatory Information Management (RIM) system is preferred.
• Prior experience implementing or maintaining an electronic Quality Management System or Regulatory system is preferred.

US base salary for this position is a minimum of USD 140,000 and maximum of USD 175,000 with an annual bonus of 15%

#LI-YA2 #LI-Remote

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.