Regulatory Affairs Specialist

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.).

Responsibilities: (include, but not limited to):

• 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 DCI 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.

Educational and Skill Requirements:

• 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.