Regulatory Compliance Specialist

Company: Quest Medical, Inc.
Location: Allen
Posted on: February 23, 2021

Job Description:

Summary: The Regulatory Compliance Specialist provides support to the regulatory team to ensure compliance with applicable regulations and to support RA initiatives (see below). This position requires an understanding of medical device regulations and fulfills the duties and responsibilities described below with guidance and direction from the Regulatory Affairs Supervisor. Initiatives: * NPD projects (regulatory assessments, design reviews, ECO reviews, PPQ reviews, labeling revisions) * International device registrations (Design Dossier compilation, CFG requests, document legalization) * Regulatory gap assessments * EU MDR compliance projects (Technical Documentation, SOP updates, CERs, PSURs, SCCP, EUDAMED submissions, etc.) * Significant change submissions (EU, Canada, US) Requirements: * Bachelor of Science degree in a relevant discipline required. * Minimum two years of experience in medical device Regulatory Affairs. * Demonstrated knowledge of FDA QSR, ISO 13485, MDD, MDR, Health Canada, and other applicable U.S. and International regulations, including experience auditing these requirements. * Knowledge of Japanese, Australian, and Brazilian requirements preferred. * Demonstrated knowledge of ISO 14971 and IEC 60601 preferred. * Experience with preparing and filing reportable events (MDRs) and Vigilance Reports. * Previous experience with FDA regulatory submissions and CE marking (510Ks, EU Technical File etc.). * Experience with the UL certification process preferred. * Excellent prioritizing, organizational, and interpersonal skills. Ability to handle multiple projects simultaneously. * Must possess technical writing, project management and fundamental problem-solving skills. * Ability to review and provide critical feedback on design documentation. * Excellent writing and communication skills. The individual should be detail-oriented and have good deductive and problem solving skills. Due to the requirements of a quality assurance environment, a certain degree of initiative and good mechanical aptitude would be advantageous. * RAPS RAC (US) preferred. * ASQ certification as a Certified Quality Auditor (CQA) preferred. Duties: * Prepares regulatory strategies and maintains submissions for U.S. and International markets, including but not limited to 510(k)s and Technical Files, to ensure timely approval of devices and continued regulatory support of marketed devices. * Reviews and summarizes post-market surveillance feedback, such as customer feedback, adverse event reporting, customer surveys, trade shows, and publications. * Evaluates and documents all alleged reportable events and field action reviews/assessments. Prepares and submits all MDRs and associated documentation to the FDA and adverse event reports to other countries within the required timeframes. Follows-up, as required, for failure investigations associated with reportable events. Interacts with the FDA and other regulatory authorities on all MDR or reportable events. * Maintains and prepares device registrations, listings, certifications, export certificates, and Declarations of Conformity. * Responsible for understanding and complying with current domestic and international regulatory requirements, including but not limited to FDA, European, Canadian, Australian, Japanese, and Brazilian requirements. * Acts as a Regulatory Affairs representative on core product development teams. Communicates regulatory requirements and impact of regulations to the development teams. Reviews design history files to ensure all regulatory requirements are being met. * Reviews and provides regulatory authorization for labeling, marketing literature, and protocols/ reports for compliance with regulatory requirements. * Evaluates, investigates, documents and communicates with both the FDA and/or other regulatory authorities on all product recalls. Writes all recall communications to the field and customers. Documents and reconciles product inventory associated with recall. Follows up with corrective action associated with recall issue. * Provides oversight of third party testing (UL, EMC, biocompatibility, sterilization assurance) as required. * Supports an effective internal audit program. Reviews processes for compliance to appropriate regulations and internal procedures. * Provides support for external audits conducted by Quest customers, regulatory authorities, and Notified Bodies. An Equal Opportunity Employer

Keywords: Quest Medical, Inc., Allen , Regulatory Compliance Specialist, Other , Allen, Texas