Pay Growth
?
out of 5
Not enough data
Not enough info to score pay or growth
Regulatory Specialist
Job
Robert Half
Newberg, OR (In Person)
Full-Time
Review key factors to help you decide if the role fits your goals.
Job Security
?
out of 5
Not enough data
Calculating job security score...
Total Score
77
out of 100
Average of individual scores
Skill Insights
Compare your current skills to what this opportunity needs—we'll show you what you already have and what could strengthen your application.
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.