Regulatory Specialist

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 ...