Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Develop, modify, evaluate, and uphold medical device labeling, encompassing product and packaging labels, Instructions for Use (IFUs), symbols, regulatory declarations, and other controlled labeling.

• Facilitate labeling modifications and approvals in collaboration with Regulatory Affairs, Quality, Engineering, Operations, and other relevant stakeholders.

• Ensure that labeling is consistent with approved registrations, product specifications, regulations, and company policies.

• Assist in the assignment and upkeep of Unique Device Identifiers (UDIs), which includes GTINs, Basic UDI-DI, UDI-DI, UDI-PI, and necessary device identifiers and product data attributes.

• Keep UDI and regulatory product information updated in the FDA GUDID, EU EUDAMED, and other applicable regional registries.

• Support GS1 Global Healthcare initiatives, GS1 Member Organizations, GLNs, GTINs, GDSN, and related data-pool standards.

• Track evolving requirements for labeling, UDI, product identification, data attributes, and regulatory databases; assist with gap and impact evaluations.

• Execute approved labeling, data, system, and process modifications.

• Ensure consistency between approved labeling, product master data, UDI databases, GS1/GDSN data, health authority databases, and information from commercial trading partners.

• Maintain precise regulatory product data and records in relevant systems.

• Facilitate system and data modifications; manage system issues and vendor assistance with IT and external providers.

• Aid in system implementations, migrations, testing, and validation processes.

• Support global regulatory submissions, registrations, renewals, notifications, and ongoing market maintenance.

• Evaluate product, manufacturing, and business modifications for their regulatory implications.

• Keep regulatory registrations, certificates, approvals, and supporting documentation current.

• Assist regulatory authorities, Notified Bodies, audits, inspections, and other regulatory inquiries.

• Facilitate regulatory efforts for new products, market expansions, manufacturing transitions, and changes in legal entities.

• Collaborate with Regulatory Affairs, Quality, Engineering, Operations, Supply Chain, Commercial, IT, and other departments throughout the product lifecycle.

⛳️ Requirements

• Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, or a related discipline; equivalent relevant experience may be taken into account.

• 2–5 years of experience in Regulatory Affairs or a related field within the medical device sector is preferred.

• Proficient understanding of medical device regulatory requirements in the U.S. and/or international markets.

• Experience in supporting regulatory submissions, registrations, change assessments, or product maintenance activities is preferred.

• Strong preference for candidates with experience in medical device labeling and UDI.

• Familiarity with FDA GUDID, EU EUDAMED, GS1, GTINs, GLNs, and/or GDSN is preferred.

• Beneficial experience with regulatory databases, document management systems, ERP systems, or labeling/artwork systems.

• Excellent attention to detail, organizational skills, analytical reasoning, and both written and verbal communication abilities.

• Capability to juggle multiple priorities and work efficiently with global, cross-functional teams.

• Experience in labeling, regulatory knowledge, eIFU management expertise, and strong data and systems competencies.

• Anticipated travel requirements 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