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Job Description
Charlie Gilmur with Robert Half is looking for a Regulatory Specialist to help sustain regulatory compliance and quality system performance for medical device products in Newberg, Oregon. This role works across engineering, quality, document control, and customer-facing teams to keep submissions, technical records, and quality documentation accurate and inspection-ready. The ideal candidate brings strong knowledge of global medical device regulations and can manage regulatory activities throughout the product lifecycle while supporting audits, labeling review, and continuous improvement efforts.
Responsibilities:
Lead the preparation, organization, and upkeep of regulatory submissions and product files for domestic and international markets. Oversee product registration, licensing, and renewal activities, ensuring approval records remain current and traceable. Evaluate design or engineering changes to determine regulatory impact and identify when additional submissions or notifications are required. Partner with internal teams to review product labeling, instructions for use, and related documentation for compliance with applicable market requirements. Maintain quality system documents such as procedures, templates, and manuals so they remain aligned with current standards and business practices. Plan and perform internal audits, document observations, and follow corrective actions through to completion. Support external inspections and third-party audits by assembling required evidence and assisting with responses to findings. Monitor changes in global regulations and standards, assess operational impact, and communicate necessary updates to stakeholders. Contribute to post-market quality and regulatory activities, including complaint analysis, adverse event reporting support, and recall documentation when needed. Provide training and practical guidance to cross-functional teams on regulatory expectations, risk management, and quality system requirements. Please reach out to Charlie Gilmur with Robert Half to review this position.
Job Order:
03600-0013441962 Bachelor's degree or equivalent relevant experience in the medical device manufacturing industry; extensive industry experience may be considered in place of a degree. Working knowledge of medical device regulatory frameworks across multiple regions, including U.S., Canadian, European, and other international markets. Experience preparing and maintaining regulatory documentation, technical files, registrations, and product compliance records. Familiarity with quality management system standards and risk management principles, including ISO 13485 and
