Regulatory Affairs Specialist - Medical Devices (Labeling/UDI)

Teleflex; Massachusetts; Híbrido; USD 87 000 - 131 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical insurance

Dental insurance

Vision insurance

401(k) plan

PTO

Disability insurance

Parental leave

Resumo da oferta

Ingenyx is seeking a Regulatory Affairs Specialist to support global regulatory activities for medical devices, focusing on labeling, UDI, and regulatory product data. You will collaborate with Regulatory Affairs, Quality, Engineering, Operations, Supply Chain, and Commercial teams to ensure ongoing compliance throughout the product lifecycle.

The role requires a bachelor’s degree and 2–5 years of regulatory experience, with strong knowledge of UDI, labeling, FDA GUDID, EU EUDAMED, and data

Qualificações

• Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, or related field.

Responsabilidades

• Create, revise, and maintain device labeling, including product labeling, IFUs, symbols, and regulatory statements.
• Coordinate labeling changes and approvals with Regulatory Affairs, Quality, Engineering, Operations, and other stakeholders.
• Maintain labeling remains aligned with registrations, requirements, and company standards.
• Assist with UDI assignment and maintenance, including GTINs and Basic UDI-DI.
• Maintain UDI and regulatory product information in health authority databases (FDA GUDID, EU EUDAMED).
• Support data pools and GS1/GDSN requirements.
• Monitor regulatory labeling, UDI, and data requirements with gap assessments.
• Implement changes from regulatory/commercial updates.
• Align labeling with product master data and partner information.

Conhecimentos

Attention to detail

Analytical thinking

Written communication

Verbal communication

Regulatory knowledge

Cross-functional collaboration

Formação académica

Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, or related field

Ferramentas

Regulatory databases

ERP systems

Labeling/artwork systems

GUDID/EUDAMED familiarity

GS1/GTIN/GLN knowledge

Descrição da oferta de emprego

Ingenyx is seeking a Regulatory Affairs Specialist to support global regulatory activities for medical devices, focusing on labeling, UDI, and regulatory product data. You will collaborate with Regulatory Affairs, Quality, Engineering, Operations, Supply Chain, and Commercial teams to ensure ongoing compliance throughout the product lifecycle.

The role requires a bachelor’s degree and 2–5 years of regulatory experience, with strong knowledge of UDI, labeling, FDA GUDID, EU EUDAMED, and data