Regulatory Affairs Specialist

🔥 2 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $87.4k - $131.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 1%

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Teleflex

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $275k Venture Round on 2010-01

Healthcare • Manufacturing • Healthcare Insurance

Teleflex is a global provider of innovative medical devices and solutions, dedicated to supporting healthcare professionals and enhancing patient care. With a diverse portfolio that includes products for anesthesia, emergency medicine, interventional cardiology, and more, Teleflex aims to improve the health and quality of lives. The company emphasizes its commitment to education and customer support in the healthcare sector.

📋 Description

• Create, revise, review, and maintain medical device labeling, including product and packaging labels, IFUs, symbols, regulatory statements, and other controlled labeling. • Coordinate labeling changes and approvals with Regulatory Affairs, Quality, Engineering, Operations, and other stakeholders. • Ensure labeling aligns with approved registrations, product requirements, regulations, and company standards. • Support UDI assignment and maintenance, including GTINs, Basic UDI-DI, UDI-DI, UDI-PI, and applicable device identifiers and product data attributes. • Maintain UDI and regulatory product information in FDA GUDID, EU EUDAMED, and applicable regional registries. • Support GS1 Global Healthcare, GS1 Member Organizations, GLNs, GTINs, GDSN, and applicable data-pool requirements. • Monitor changing labeling, UDI, product identification, data attribute, and regulatory database requirements; support gap and impact assessments. • Implement approved labeling, data, system, and process changes. • Maintain alignment between approved labeling, product master data, UDI databases, GS1/GDSN data, health authority databases, and commercial trading partner information. • Maintain accurate regulatory product data and records in applicable systems. • Support system and data changes; coordinate system issues and vendor support with IT and external providers. • Support system implementations, migrations, testing, and validation. • Support global regulatory submissions, registrations, renewals, notifications, and market maintenance. • Assess product, manufacturing, and business changes for regulatory impact. • Maintain regulatory registrations, certificates, approvals, and supporting documentation. • Support regulatory authorities, Notified Bodies, audits, inspections, and other regulatory requests. • Support regulatory activities for new products, market expansions, manufacturing transfers, and legal entity changes. • Collaborate with Regulatory Affairs, Quality, Engineering, Operations, Supply Chain, Commercial, IT, and other functions throughout the product lifecycle.

🎯 Requirements

• Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, or a related field; equivalent relevant experience may be considered. • 2–5 years of Regulatory Affairs or related medical device experience preferred. • Working knowledge of medical device regulatory requirements in the U.S. and/or international markets. • Experience supporting regulatory submissions, registrations, change assessments, or product maintenance activities preferred. • Experience with medical device labeling and UDI strongly preferred. • Familiarity with FDA GUDID, EU EUDAMED, GS1, GTINs, GLNs, and/or GDSN preferred. • Experience with regulatory databases, document management systems, ERP systems, or labeling/artwork systems is beneficial. • Strong attention to detail, organization, analytical thinking, and written and verbal communication skills. • Ability to manage multiple priorities and work effectively with global, cross-functional teams. • Labeling experience, regulatory awareness, eIFU management knowledge, and strong data and systems skills. • Expected travel of up to 10%.

🏖️ Benefits

• Medical insurance • Prescription drug insurance • Dental insurance • Vision insurance • Flexible spending accounts • Participation in 401(k) savings plan • Paid time off (PTO) • Short-term disability • Long-term disability • Parental leave