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United States
Remote only
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Regulatory Affairs Specialist, Labeling (SWICC) based in the United States.
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.
As the principal regulatory expert for labeling and UDI, you will establish regulatory requirements, guide product teams, and ensure consistent compliance across multiple markets. Your responsibilities will include:
Lead regulatory labeling strategy discussions and serve as the subject matter expert for medical device labels, instructions for use (IFUs), packaging, and electronic labeling.
Manage a large portfolio of labels and label versions, tracking change requests and ensuring labeling remains current and compliant.
Monitor FDA, EU, and international regulatory developments related to labeling and UDI, assessing their impact on existing products and communicating required actions and timelines to relevant stakeholders.
Define labeling requirements for each product family based on intended use, regulatory classification, product claims, and target markets.
Work with international business units and local regulatory teams to identify, interpret, and implement country-specific requirements across the EU, Canada, Australia, the United Kingdom, the Middle East, Asia, and Latin America.
Maintain oversight of regional language, translation, symbol, importer, and authorized representative requirements.
Review labeling and promotional materials for regulatory compliance, including claims, symbols, artwork, barcodes, translations, and electronic labeling.
Serve as the UDI subject matter expert, providing guidance on FDA and international UDI requirements, including GS1 and GTIN standards.
Act as, or support, the accountable person for GUDID and EUDAMED submissions and ongoing data maintenance, ensuring consistency with approved labeling and product registrations.
Support engineering and labeling changes by coordinating regulatory assessments through change request and product lifecycle management (PLM) processes.
Provide expert guidance to R&D, Quality, Marketing, Manufacturing, and Product Management teams during new product development, product changes, and remediation initiatives.
Ensure labeling requirements are incorporated early into product development and contribute labeling-related input to risk management documentation in accordance with ISO 14971.
Support 510(k), De Novo, EU MDR technical documentation, and international product registrations by providing regulatory labeling expertise.
Develop and maintain labeling and UDI procedures, work instructions, templates, and style guides.
Contribute to process improvements, corrective and preventive actions (CAPA), and audit-related activities involving labeling.
Represent the labeling and UDI function during internal and external audits, including FDA, notified body, and MDSAP audits.
Develop and deliver training on labeling and UDI requirements, providing guidance to colleagues across regulatory and labeling teams.
Review labeling redlines and coordinate with translation vendors and internal stakeholders to verify accuracy and regulatory compliance before release.
Support additional regulatory and labeling projects as required.
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%.
Annual base salary ranging from $120,160 to $150,000, depending on experience.
Additional eligibility for a 15% Short-Term Incentive Plan (STIP).
Health, dental, and vision insurance.
401(k) retirement plan with company matching contributions.
Paid time off.
Wellness initiatives and health assistance resources.
Life insurance.
Short-term and long-term disability benefits.
Health and dependent care Flexible Spending Accounts (FSAs).
Commuter benefits.
Parental and caregiver leave.
Tuition reimbursement.
Remote working arrangement.
Monday–Friday schedule, 8:30 a.m. to 5:00 p.m.