Quality Assurance Regulatory Affairs Manager

 SUMMARYAnsh Labs is hiring a Manager, Regulatory Affairs & Quality Assurance. The qualified candidate will serve a vital role in developing, coordinating, implementing, and maintaining quality management processes in support of the development, approval, and successful manufacture of our products in adherence to all applicable regulatory requirements and standards set forth in the company's quality manual and standard operating procedures in accordance with customer requirements. This role will also monitor manufacturing, development, quality, and regulatory processes to ensure conformance and compliance with all FDA and applicable international regulations and execute regulatory activities according to project plans to assure new products meet submission, approval, and commercial launch goals. Related activities include compiling and writing FDA and IVDR reports as well as coordinating the completion of technical file requirements across multiple departments; and lead domestic and international regulatory and product registrations working directly with local customers and distributors. ESSENTIAL JOB DUTIESQuality System ManagementOversee the Company Quality Management System and Regulatory policies, procedures, and processes to ensure they are compliant to relevant requirements including, 21 CFR Part 820, IVD Directive 9879 EC, IVDR 2017746, as well as ISO 13485:2016 and other relevant international regulations. Serve as the Company Quality Management Representative and Person Responsible for Regulatory Compliance (PRRC), including representing the Quality Assurance and Regulatory department on project teams and audits.Lead, manage, andor conduct internal, certified bodies, regulatory, customer, and third-party audits to ensure compliance with applicable regulatory governing bodies, standards, customer requirements, and procedures, including FDA, EU Notified Body and vendors.Prepare and maintain audit documentation, including responses to findings and implementation of corrective actions.Ensure readiness for external inspections by maintaining compliance with quality and regulatory standards.Collaborate with cross-functional teams to address audit-related requirements and ensure continuous improvement.Oversee the control of documents, including standard operating procedures (SOPs), manufacturing work instructions (MWIs), and product specifications.Quality Control and Compliance Monitor manufacturing processes to ensure consistent quality and compliance to processes and procedures as stipulated in the quality manual and in accordance with current Good Manufacturing Practices (cGMP) where applicable.Perform andor lead root cause analyses for non-conformance events and implement corrective and preventative (CAPA) actions.Work closely with VION regulatory teams to ensure products meet applicable FDA, EU MDR, and other relevant standards where applicable. Manages activities associated with the Company's CAPA, complaints, and nonconformance review processes.Handle customer complaints by investigating root causes, collaborating with internal teams to resolve issues, and ensuring timely communication with customers.Maintain a complaint-handling system to track, analyze, and address complaints and recurring issues effectively.Assist in the establishment of baseline data for creation of Key Performance Indicators (KPI's) for monitoring key quality metrics that drive continuous improvement and allow for effective means of controlling the Cost of Quality (COQ).Regulatory ComplianceDevelop and implement global regulatory strategies for development, submission, registration, and maintenance of in vitro diagnostic (IVD) products through all phases of product life-cycle.Provide direction and oversight of evaluation of the regulatory impact of changes associated with product design change and routine change control in domestic and international markets.Drive clinical and commercial regulatory strategies for assigned products to enable successful study designs and timely registration of diagnostic products by relevant regulatory health authorities.Participate in preparation, review, and approval of key IVD regulatory submissions and certifications with US and international health authorities including 510(k)s, EU Notified Body certifications, etc. Negotiate directly with relevant Quality and Regulatory authorities to obtain and to maintain product clearances.Ensure international product distribution activities are compliant with applicable regulatory requirements.Lead activities associated with post market surveillance, vigilance, adverse events, medical device reportable events and product recall activities, including notifications, corrections, and removals in international markets, if required.Assess the impact of relevant regulations on IVD product development, registration, and commercialization activities.Other duties as assigned.Process and Product ImprovementAnalyze quality data and identify trends to proactively improve processes and product quality.Collaborate with R&D, production, and supply chain teams to address quality concerns during product development and manufacturing.Conduct risk analysisassessments to identify and mitigate potential quality issues.Participate in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities to validate processes and product designs.Training and SupportTrain staff and assure maintenance of appropriate training records and training effectiveness on quality standards, procedures, and best practices.Coordinate management reviews and maintain recordkeeping of meeting minutes.Maintain tech-support records and support customer inquiries by providing technical expertise and ensuring prompt resolution.QUALIFICATIONSBachelorsMasters in Biotechnologyrelated field (life sciences, biotech engineering, chemistry).Must be eligible to work in the United States without VISA sponsorship.EXPERIENCE5+ years of experience working in a Regulatory or Quality position with a minimum of 2+ years at a medical device company, preferably IVD.Strategic experience and ability, having demonstrated success related to the development and implementation of pre-clinical and clinical strategies for clinical and life-science IVD products, implementation of regulatory systems, and assuring compliance to all applicable regulations.Strong knowledge of US FDA Quality System Regulations 21 CFR 820, ISO 13485, and EU (CE) Regulations (IVDDIVDR) is essential.Proficient in quality compliance, such as CAPA, Root Cause Analysis, Validation, and Process Controls.Solid scientific analytical evaluation skills.Demonstrated communication and human relation skills.Ability to work well within cross-functional teams.Technical writing ability a MUST.Proficient using Word and Excel applications and Windows operating system.Must be able to work effectively in a fast-paced, team-oriented environment.Ability to work independently with minimal supervision.Demonstrated cross-functional teamwork skills.Self-starting, detail oriented, and ability to focus on task at hand.Well-developed English written and verbal communication skills.WORK ENVIRONMENT:Full-time, salaried position, with benefits (Health, Dental, Vision and 401K). Work schedule: Monday-Friday; 8:30 AM - 5:30 PM.Based in the Continental United States - Webster, Texas.Must be willing to occasionally travel as terested Candidates are encouraged to submit their resumecv to:

Created: 2025-02-21