Job Description

Regulatory Affairs Specialist – Medical Device Industry - $80k - $85k Exton, PA US Citizen or Green card holders only No C2C A leading medical device technology company is seeking a Regulatory Affairs Specialist to join their team. You will specialize in the design and manufacturing of cutting-edge spinal implants and surgical instrumentation. Their commitment to innovation, quality, and excellence has made them a trusted name in the industry. What You Will Do: Ensure regulatory compliance by implementing and maintaining internal procedures aligned with industry standards and regulations. Support daily regulatory affairs activities under the guidance of the RA/QA manager. Maintain compliance with ISO 13485, FDA, and international regulatory requirements through quality assurance procedures and audits. Act as a liaison with regulatory agencies to ensure full compliance with US and international regulations. Assist in FDA inspections, Notified Body audits, and internal audits; contribute to audit responses and corrective actions. Manage and update US and international regulatory registrations and licenses . Represent regulatory affairs in project planning and design control meetings. Track and report on FDA submissions, ISO 13485 compliance, and design deliverables. Provide regulatory guidance on device packaging labels, Instructions for Use (IFUs), promotional materials, and sales training content . Review and audit FDA premarket submissions, including 510(k) Premarket Notifications . Requirements: ~ Bachelor’s degree in a scientific or engineering field or equivalent experience. ~5+ years of experience in regulatory affairs within the medical device industry. ~ Experience leading FDA inspections and ISO audits is a plus. ~ Strong knowledge of FDA regulations, CE marking, risk analysis, and ISO standards . ~ Experience with 510(k) submissions, Investigational Device Exemptions (IDEs), and Premarket Approval Applications (PMAs). ~ Proficient in MS Office and CAD software (Creo preferred) . ~ Understanding of ISO 13485, ISO 14971, cGMP , and other medical device quality systems (certifications a plus). ~ Familiarity with FDA Unique Device Identification (UDI) regulations and GS1 data standards is beneficial. ~ Ability to use calipers, micrometers, and mechanical inspection tools (RAM and Overlay experience a plus). ~ Strong attention to detail, problem-solving skills, and a team-oriented mindset.

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