Biomedical Device Compliance and Regulatory Affairs Specialist

Location: Little Elm, TX

Department: Regulatory Affairs

Ensure medical device manufacturing compliance with US Food and Drug Administration Quality System Regulation (QSR), ISO 13485 (Quality Management System for Medical Device Manufacturing), Medical Devices Directive (MDD), Medical Device Regulation (MDR), Health Canada, and other applicable US and international regulations for all existing products; update technical documentation and post market surveillance documentation from MDD to MDR; ensure ongoing maintenance of medical device technical and risk management documentation in alignment with current regulatory requirements;

ensure medical device product post market surveillance and revision of related risk management, as applicable; support new medical device product development; compile European Union (EU) MDR Technical documentation for submission to notified body per compliance plan schedule; assist with internal and supplier audit programs structured around domestic and international medical device manufacturing regulations; provide regulatory support for third party audits of quality systems and product documentation;

support and maintain technical documentation, MDR certification, and declarations of conformity in support of EU product registrations/Conformité Européenne (CE) marking; review all technical documentation including design verification and validation protocols and reports, manufacturing process information, biocompatibility evaluation reports, list of applicable standards, list of general safety and performance requirements (GSPR), declaration of conformity and clinical data; collaborate with Regulatory Manager to develop implementation plan to complete updates to technical documentation;

update post market surveillance plans and reports annually and periodic safety update report (PSUR) submissions as required; work with the Product Development department to create and maintain Design History File (DHF) documents and technical documentation.

Minimum Qualifications: Must have a Bachelors in Biomedical Engineering, Bioengineering, Biomechanical Engineering, Biotechnology, Biochemical Engineering, or related field plus 2 years of experience as a Biomedical Engineer, Quality Engineer, or in a substantially similar position.

Special

Skills Required:

Required experience must include risk management and regulatory requirements for medical device manufacturing.

Work Hours : 9 AM to 6 PM