Job Description

Job Description

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 ISO 14971.
• Ability to assess engineering changes, product development updates, and labeling revisions for regulatory significance.
• Experience participating in internal audits, external audits, or regulatory inspections within a regulated manufacturing environment.
• Strong document control, organization, and cross-functional communication skills.
• Proficiency supporting quality assurance and regulatory compliance activities for medical device or closely related regulated products.

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