Principal Regulatory Affairs Specialist, Labeling (SWICC)

About Getinge

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.

Job Overview

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.

Job Responsibilities and Essential Duties:

• 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 requirements, so that one labeling approach meets requirements across markets.
• Maintains a current view of labeling, language and symbol requirements by region (EU, Canada, Australia, United Kingdom, Middle East, Asia and Latin America), including local-language, translation, importer and authorized representative information requirements.
• Assesses regulatory changes and new requirements against existing SWICC consumable labeling and products, documents the impact, and recommends and tracks the required changes.
• Defines the regulatory labeling requirements for each SWICC consumable product family based on its intended use, classification (FDA Class I and II; EU MDR Class I, IIa and IIb), claims and target markets (US, EU, rest of world).
• Develops and/or reviews labeling and promotional materials for regulatory compliance, including claims, symbols and language requirements, before release.
• Serves as the UDI subject matter expert for SWICC consumables. Provides guidance on FDA and worldwide UDI and GTIN requirements.
• Acts as, or supports, the accountable person for GUDID and EUDAMED data submissions and maintenance for SWICC consumables, ensuring the data matches approved labeling and registrations.
• Supports engineering and labeling changes by routing the regulatory assessment through the change request and product lifecycle management (PLM) process in compliance with the Quality System.
• Provides leadership and expert guidance to R&D, Quality, Marketing, Manufacturing and Product Management on new product development, product changes and remediation projects so labeling requirements are built in early, and provides labeling input to risk management files (ISO 14971).
• Provides expert support with all 510(k), De Novo, and/or EU MDR technical documentation and international registrations with labeling content and requirements, and reviews artwork, barcodes, translations and e-labeling for compliance.
• Authors and/or contributes to labeling and UDI procedures, work instructions, style guides and templates, and supports process improvements, CAPA and audit actions related to labeling.
• Serves as the labeling and UDI subject matter expert with internal and external auditors, including FDA, notified bodies and MDSAP auditors.
• Develops and delivers training on labeling and UDI requirements, and provides guidance to colleagues across the regulatory and labeling teams.
• Reviews labeling redlines and verifies translations with translation vendors and internal teams for accuracy and regulatory compliance before release.
• Assists in special projects as needed.

Required Knowledge, Skills and Abilities:

• Expert knowledge of labeling, PLM and change control, and MS Office applications (Word, Excel).
• Team player who communicates and collaborates proactively with various cross-functional teams such as: R&D, Quality, Marketing and Regulatory colleagues to achieve corporate and project goals.
• Expert ability to interpret regulations and explain labeling requirements and their impact to non-regulatory stakeholders.
• Able to work with international business units and local regulatory colleagues across regions, languages and time zones to resolve country-specific labeling questions.
• Must be detail-oriented and possess excellent organizational skills with a demonstrated ability to manage a high volume of labels and label versions and multiple projects with deadlines.
• Strong interpersonal communication and negotiation skills.

Minimum Requirements: 

• Expert knowledge of FDA 21 CFR Part 801 (labeling), 21 CFR Part 830 (UDI) and 21 CFR Part 820, EU MDR 2017/745, MDSAP and ISO 13485.
• Expert knowledge of international medical device labeling requirements beyond the US, including the EU, Canada, Australia, United Kingdom, Middle East, Asia and Latin America, and experience adapting and managing labeling for multiple countries and languages.
• Experience with single-use consumable medical devices. Strong specialty knowledge and experience with national and international medical device labeling regulations and requirements, including ISO 15223-1 (symbols) and ISO 20417 (information supplied by the manufacturer).
• Hands-on experience with UDI, GS1/GTIN, GUDID and EUDAMED data requirements.
• Minimum 7 years of medical device regulatory affairs experience, including at least 3 years supporting medical device labeling. Medical device experience is required.
• Experience managing a high volume of labels and label versions through change control and PLM systems.
• Bachelor's degree in a scientific, engineering or related field.

Environmental/Safety/Physical Work Conditions: 

• Ensures environmental consciousness and safe practices are exhibited in decisions
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
• May work extended hours during peak business cycles
• Physical requirements such as lifting specific weights
• Travel up to 20% 

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The salary range for this position is between $120,160-$150,000 per year depending on experience, + 15% STIP

Monday-Friday, 8:30am-5pm

#LI-LG1 #LI-Remote