Principal Regulatory Affairs Specialist, Labeling (SWICC)

Getinge•East Lansing, MI

12d•$120,160 - $150,000•Remote

About The Position

The Principal Regulatory Affairs Labeling Specialist is the regulatory subject matter expert and lead for medical device labeling and Unique Device Identification (UDI) for Surgical Workflows - Infection Control Consumables (SWICC). The role covers consumable medical devices across FDA Class I and II, EU MDR Class I, IIa and IIb, 510(k) and De Novo pathways, and markets in the US, EU and rest of world. The specialist owns regulatory intelligence for labeling, monitors worldwide labeling and UDI requirements, evaluates changes against current products and labeling, and advises the business on changes needed and timing. The position defines and establishes the regulatory requirements process, identifies and reviews product-specific labeling requirements for compliance, and confirms alignment with the quality system. It manages a large volume of labels and versions and guides cross-functional teams on applicable requirements. With global scope, the specialist works with international business units and local regulatory teams to define and maintain country-specific labeling requirements. The role is also the UDI subject matter expert and may be accountable for EUDAMED and GUDID data submissions. The position is remote, with a Monday–Friday schedule of 8:30 a.m.–5:00 p.m. Travel is up to 20%. The role may require extended hours during peak business cycles and physical requirements such as lifting specific weights. The salary range is $120,160–$150,000 per year, depending on experience, plus 15% STIP.

Requirements

Expert knowledge of labeling, PLM, change control and MS Office applications, including Word and Excel.
Ability to collaborate proactively with cross-functional teams, including R&D, Quality, Marketing and Regulatory colleagues.
Expert ability to interpret regulations and explain labeling requirements and their impact to non-regulatory stakeholders.
Ability to work with international business units and local regulatory colleagues across regions, languages and time zones to resolve country-specific labeling questions.
Detail-oriented, with excellent organizational skills and demonstrated ability to manage high volumes of labels and versions, multiple projects and deadlines.
Strong interpersonal communication and negotiation skills.
Expert knowledge of FDA 21 CFR Part 801, 21 CFR Part 830 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 and strong specialty knowledge of national and international medical device labeling regulations, including ISO 15223-1 and ISO 20417.
Hands-on experience with UDI, GS1/GTIN, GUDID and EUDAMED data requirements.
At least 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 versions through change control and PLM systems.
Bachelor's degree in a scientific, engineering or related field.
Ability to use computer and telephone equipment and other related office accessories/devices to complete assignments.
Ability to meet physical requirements such as lifting specific weights; reasonable accommodations may be made.

Responsibilities

Lead regulatory labeling strategy discussions and serve as the labeling subject matter expert for SWICC consumable medical devices, including labels, instructions for use, packaging and electronic labeling.
Manage a high volume of labels and versions, track changes across the portfolio, keep labeling current, and guide R&D, Quality and Marketing teams on applicable requirements.
Monitor FDA, EU and international labeling and UDI requirements and communicate changes to R&D, Quality, Marketing and Product Management.
Work with international business units and local regulatory teams to identify, interpret and implement country-specific labeling requirements.
Maintain current information on regional labeling, language and symbol requirements, including local-language, translation, importer and authorized representative information requirements.
Assess regulatory changes against existing labeling and products, document impacts, and recommend and track required changes.
Define regulatory labeling requirements for each SWICC consumable product family based on intended use, classification, claims and target markets.
Develop and/or review labeling and promotional materials for regulatory compliance before release.
Provide guidance on FDA and worldwide UDI and GTIN requirements.
Act as or support the accountable person for GUDID and EUDAMED data submissions and maintenance, ensuring data matches approved labeling and registrations.
Support engineering and labeling changes by routing regulatory assessments through change request and PLM processes in compliance with the Quality System.
Provide leadership and expert guidance to R&D, Quality, Marketing, Manufacturing and Product Management on product development, changes and remediation; provide labeling input to ISO 14971 risk management files.
Support 510(k), De Novo, EU MDR technical documentation and international registrations with labeling content and requirements; review artwork, barcodes, translations and e-labeling for compliance.
Author or contribute to labeling and UDI procedures, work instructions, style guides and templates, and support process improvements, CAPA and audit actions related to labeling.
Serve as the labeling and UDI subject matter expert with internal and external auditors, including FDA, notified bodies and MDSAP auditors.
Develop and deliver training on labeling and UDI requirements and guide colleagues across regulatory and labeling teams.
Review labeling redlines and verify translations with translation vendors and internal teams for accuracy and regulatory compliance before release.
Assist with special projects as needed.
Exhibit environmental consciousness and safe practices in decisions.