Principal Regulatory Affairs Specialist, Labeling; SWICC)

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Date:
Oct 29, 2026

Location:

Lansing, MI, US

Remote Work: 5 days at home (fully remote)

Salary Range: $120,160-$150,000 per year depending on experience

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 product's 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 proud of our heritage and the passion we have in belonging to Getinge and how our employees can share in being part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team.

Surgical Workflows - Infection Control Consumables (SWICC) covers the consumable medical devices used in the Sterile Processing Department (SPD) to clean, process, and prepare reusable surgical instruments after use in the operating room. The Principal Regulatory Affairs Labeling Specialist is the regulatory subject matter expert and lead for medical device labeling and Unique Device Identification (UDI) for SWICC consumable medical devices (FDA Class I and II;

EU MDR Class I, IIa and IIb; 510(k) and De Novo; US, EU and rest of world). This person owns regulatory intelligence for labeling: they monitor changes to labeling and UDI requirements worldwide, assess those changes against current products and labeling, and tell the business what must change and by when. The Principal Regulatory Affairs Labeling Specialist will define and establish the regulatory requirements process.

They will identify specific product labeling requirements, review them for compliance, and confirm they conform to the quality system. This role manages a large volume of labels and many label versions across SWICC consumables and guides teams on the labeling requirements. The role is global in scope: it works with Getinge international business units to define and maintain country-specific labeling requirements and give guidance to the project teams, not only US and EU requirements.

The role also serves as the UDI subject matter expert and may serve as the accountable person for EUDAMED and GUDID data submissions.

• Leads all regulatory labeling strategy discussions and serves as the regulatory subject matter expert for medical device labeling for SWICC consumable products, including labels, instructions for use (IFU), packaging, and electronic labeling.
• Manages a high volume of labels and label versions for SWICC consumables: tracks versions and change requests across the portfolio, keeps labeling current as requirements change, and guides R&D, Quality and Marketing teams on the labeling requirements that apply.
• Owns regulatory intelligence for labeling: monitors FDA, EU and other international labeling and UDI requirements, and communicates new or changed requirements to R&D, Quality, Marketing and Product Management.
• Serves as the global labeling expert for SWICC consumables: works with Getinge international business units and local regulatory teams to identify, interpret and implement country-specific labeling…