Principal Regulatory Affairs Specialist, Labeling (SWICC)

The Principal Regulatory Affairs Specialist will serve as the global regulatory authority for medical device labeling and Unique Device Identification (UDI) across a portfolio of surgical workflow and infection control consumables. This role ensures that product labels, packaging, instructions for use, and promotional materials comply with evolving regulatory requirements across the United States, Europe, and international markets. You will lead labeling strategies, oversee a high volume of label versions, and translate complex regulatory changes into clear actions for cross-functional teams. Working closely with R&D, Quality, Marketing, Manufacturing, and international regulatory colleagues, you will help maintain product compliance throughout the product lifecycle. You will also guide UDI data management, support regulatory submissions, and contribute to audits and quality system improvements. This is a global, highly specialized opportunity to influence regulatory excellence and help ensure the safe and effective use of medical devices worldwide.

The ideal candidate brings extensive medical device regulatory affairs experience, specialized expertise in international labeling requirements, and the ability to influence cross-functional teams in a complex global environment. The following qualifications and skills are required:

• Bachelor's degree in a scientific, engineering, or related discipline.

• At least 7 years of experience in medical device regulatory affairs, including a minimum of 3 years specifically supporting medical device labeling.

• Required professional experience in the medical device industry, preferably involving single-use consumable medical devices.

• Expert knowledge of FDA 21 CFR Part 801 (labeling), 21 CFR Part 830 (UDI), and 21 CFR Part 820.

• Strong understanding of EU Medical Device Regulation (MDR) 2017/745, MDSAP requirements, and ISO 13485.

• Extensive knowledge of international medical device labeling regulations beyond the United States, including requirements in Europe, Canada, Australia, the United Kingdom, the Middle East, Asia, and Latin America.

• Experience managing labeling requirements across multiple countries, languages, and regulatory jurisdictions.

• Strong knowledge of ISO 15223-1 (medical device symbols) and ISO 20417 (information supplied by the manufacturer).

• Hands-on experience with UDI requirements, GS1/GTIN standards, GUDID, and EUDAMED data management.

• Demonstrated experience managing high volumes of labels and label versions through change control and PLM systems.

• Expert understanding of labeling processes, product lifecycle management, and regulatory change control.

• Proficiency in Microsoft Office applications, particularly Word and Excel.

• Ability to interpret complex regulations and communicate their practical implications clearly to non-regulatory stakeholders.

• Strong collaboration and communication skills, with the ability to work effectively across R&D, Quality, Marketing, and Regulatory teams.

• Experience working with international business units and local regulatory colleagues across different regions, languages, and time zones.

• Excellent organizational skills and attention to detail, with the ability to manage multiple projects, deadlines, and competing priorities.

• Strong interpersonal, presentation, and negotiation skills.

• Ability to work extended hours during peak business periods when necessary.

• Willingness to travel up to 20%.