Easter Seals Jobs

POSITION SUMMARY:

This position involves working closely with internal teams, regulatory bodies, and clients to facilitate the timely registration of medical devices for manufacturing and distribution. The specialist will manage registrations, maintain compliance with FDA, EU MDR, and other relevant agencies, and support product development through the entire lifecycle, from design to post-market activities. The role will also be extensively involved in remediating legacy products to current standards for release.

ESSENTIAL DUTIES and RESPONSIBILITIES:

• Provides regulatory affairs support for all aspects of product development and manufacturing;

• Regulatory maintenance on medical device designs;

• Customer EU-MDR data requests and certifications;

• Reach, RoHS, and Prop 65 analysis and certification;

• UDI 2D data matrix compliance with existing and new designs;

• Customer and regulatory body audits;

• Evaluate and process customer complaints;

• Design change regulatory assessments;

• EU-MDR design review and remediation;

• Other tasks as assigned by supervisor;

KNOWLEDGE and SKILLS:

• Polished interpersonal, documentation, and communication skills are a must;

• Confidence presenting to large groups both online and in person;

• Strong working knowledge of Microsoft Office;

• Knowledge of 21 CFR 814, 21 CFR 820, and other FDA guidance;

• Knowledge of ISO 13485;

• Ability to drive individual tasks and projects to completion;

EDUCATION and EXPERIENCE:

• Bachelor’s degree or equivalent combination of education and applicable job experience in the medical device industry;

• Familiarity with working in a regulated environment;

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