Regulatory Specialist

Position Title: Regulatory Specialist

Position

Description:

Protingent Staffing has an exciting direct hire Regulatory Specialist opportunity.

• The Regulatory Specialist is responsible for coordinating and maintaining documentation to support global regulatory compliance and quality system objectives.
• This includes managing international product registrations, preparing regulatory submissions, conducting internal audits, and maintaining QMS documentation.
• The Regulatory Specialist collaborates with cross-functional teams including Engineering, Quality, Document Control, and Customer Service to ensure regulatory files and product records are accurate, audit-ready, and aligned with current regulations (FDA, EU MDR, ISO 13485, etc.).

• Interpret and apply regulatory requirements for domestic and international markets (e.g., FDA, EU MDR, Health Canada, TGA, Japan).
• Prepare, submit, and maintain regulatory documentation including 510(k) s, CE Technical Files, and Certificates for Foreign Governments.
• Manage global registration and listing activities; maintain accurate tracking of product approvals and renewals.
• Maintain communication with regulatory authorities, notified bodies, and international representatives (e.g., sponsors, MAHs), in accordance with our client s QMS SOPs.
• Review and assess Engineering Change Orders (ECOs) for potential regulatory impact or classification as significant changes.
• Assist with the development and review of product labeling (e.g., IFUs, package labeling, UDI data) to ensure global compliance.
• Monitor evolving regulations and standards (e.g., ISO 13485, ISO 14971, MDSAP) and assess their impact on business operations.
• Maintain and update quality management system documentation (Quality Manual, SOPs, procedures, templates).
• Develop and maintain QMS training documentation and ensure training plans are current and audit ready.
• Coordinate and conduct internal audits; issue audit reports and track corrective actions.
• Participate in third-party audits and FDA inspections, providing documentation and supporting responses to findings.
• Support post-market surveillance (PMS) activities including complaints trending, CAPA coordination, adverse event reporting, and recall documentation.
• Participate in risk management activities per ISO 14971 and in product development reviews to ensure compliance with applicable requirements.
• Provide cross-functional training and guidance on regulatory and QMS-related topics.
• Maintain audit-ready technical documentation and regulatory files throughout the product lifecycle.
• Support or lead continuous improvement projects related to regulatory or QMS compliance.
• Perform additional duties as assigned by the Quality Assurance and Regulatory Affairs Manager.

• Knowledge and experience with applicable FDA, Health Canada, ISO, MDD requirements (Legacy Products-Article 120 compliance), MDR Regulations.
• ISO 14971:2019 Risk management.
• Certification to ISO 13485:2016 and MDSAP
• Ability to support Product Development projects.
• Bachelor’s degree or a minimum of 10 years’ experience in the medical device manufacturing industry.
• Physical Requirements:
• Must be able for sit for long periods of time at a computer workstation.

• Job type:
  Direct Hire
• Location:
  
  Newberg, OR (Onsite).
• Salary Range: $75K-$115K.