Regulatory Specialist

Job Description
Position Title:
Regulatory Specialist

Position Description:
Protingent Staffing has an exciting direct hire Regulatory Specialist opportunity.

Job Description:

• 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.).

Job Responsibilities:

• 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.

Job Qualifications:

• 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 Details:

• Job type: Direct Hire


• Location: Newberg, OR (Onsite).


• Salary Range: $75K-$115K.

About Protingent:
Protingent is an
Award-Winning
provider of top-tier Engineering and IT talent, trusted by companies at the forefront of innovation — from
Software and Aerospace
to
AI, Clean Tech, Medical Devices, and Connected Technologies
. We’re passionate about making a positive impact by connecting exceptional talent with meaningful opportunities and helping our clients build the future.