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1 result for Telecommunications Specialist in Portland, OR
- Newberg, OR
- onsite
- Permanent / Full Time
- 0 - 0 USD / Yearly
- <p>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.</p><p><br></p><p>Responsibilities:</p><p>• Lead the preparation, organization, and upkeep of regulatory submissions and product files for domestic and international markets.</p><p>• Oversee product registration, licensing, and renewal activities, ensuring approval records remain current and traceable.</p><p>• Evaluate design or engineering changes to determine regulatory impact and identify when additional submissions or notifications are required.</p><p>• Partner with internal teams to review product labeling, instructions for use, and related documentation for compliance with applicable market requirements.</p><p>• Maintain quality system documents such as procedures, templates, and manuals so they remain aligned with current standards and business practices.</p><p>• Plan and perform internal audits, document observations, and follow corrective actions through to completion.</p><p>• Support external inspections and third-party audits by assembling required evidence and assisting with responses to findings.</p><p>• Monitor changes in global regulations and standards, assess operational impact, and communicate necessary updates to stakeholders.</p><p>• Contribute to post-market quality and regulatory activities, including complaint analysis, adverse event reporting support, and recall documentation when needed.</p><p>• Provide training and practical guidance to cross-functional teams on regulatory expectations, risk management, and quality system requirements.</p><p><br></p><p>Please reach out to Charlie Gilmur with Robert Half to review this position. Job Order: 03600-0013441962</p><p><br></p>
- 2026-06-02T00:00:00Z