Medical Device Regulatory Affairs Specialist

Halpin Staffing Services; Racine (WI); In loco; USD 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

Halpin Staffing Services is seeking a Regulatory Affairs Specialist to support regulatory compliance, registrations, and QA activities for medical devices. You will prepare regulatory documents, ensure FDA and international compliance, and collaborate with internal teams and external stakeholders to maintain high standards.

The role involves post-market surveillance, change notifications, and contributing regulatory guidance in design reviews and audits, with a focus on ISO 9001/13485 aligned

Competenze

• Bachelor’s degree in a technical field or five years of relevant experience
• At least 2 years in quality assurance or regulatory affairs
• Experience with medical devices regulatory work preferred
• Familiarity with FDA and international rules and ISO 9001/13485

Mansioni

• Assist with medical device registrations and regulatory submissions
• Prepare and maintain regulatory docs, files, and labeling
• Ensure compliance with FDA and international requirements
• Support EU Declarations of Conformity and regulatory records
• Assist with post-market surveillance and regulatory reporting
• Coordinate regulatory notifications for product changes
• Support communications with customers, distributors, and authorities
• Provide regulatory guidance in design meetings and audits
• Contribute to CAPA, recalls, and field corrections processes
• Participate in Quality Steering Team meetings and audits

Conoscenze

Regulatory knowledge

Quality assurance

Documentation

Regulatory communications

Microsoft Office

Formazione

Bachelor's degree in Science/Healthcare/Engineering/related field

Strumenti

Microsoft Office

ISO 9001 knowledge

ISO 13485 knowledge

Descrizione del lavoro

Halpin Staffing Services is seeking a Regulatory Affairs Specialist to support regulatory compliance, registrations, and QA activities for medical devices. You will prepare regulatory documents, ensure FDA and international compliance, and collaborate with internal teams and external stakeholders to maintain high standards.

The role involves post-market surveillance, change notifications, and contributing regulatory guidance in design reviews and audits, with a focus on ISO 9001/13485 aligned