What are the responsibilities and job description for the Quality Assurance Regulatory Affairs Manager position at Ansh Labs, a VION Biosciences company?
Summary
Ansh Labs is hiring a Manager, Regulatory Affairs & Quality Assurance. This role will serve as a vital link in developing, coordinating, implementing, and maintaining quality management processes in support of the development, approval, and successful manufacture of our products in accordance with all applicable regulatory requirements and standards.
Job Description:
Quality System Management
- Oversee the Company Quality Management System and Regulatory policies, procedures, and processes to ensure compliance with relevant requirements.
- Serve as the Company Quality Management Representative and Person Responsible for Regulatory Compliance (PRRC).
- Lead, manage, and/or conduct internal, certified bodies, regulatory, customer, and third-party audits to ensure compliance with applicable regulatory governing bodies, standards, customer requirements, and procedures.
- Prepare and maintain audit documentation, including responses to findings and implementation of corrective actions.
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 and/or 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.
Regulatory Compliance
- Develop 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.
Process and Product Improvement
- Analyze 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.
Training and Support
- Train staff and assure maintenance of appropriate training records and training effectiveness on quality standards, procedures, and best practices.
- Maintain tech-support records and support customer inquiries by providing technical expertise and ensuring prompt resolution.
- Bachelors/Masters in Biotechnology/related field (life sciences, biotech engineering, chemistry).
- Must be eligible to work in the United States without VISA sponsorship.
- 5 years of experience working in a Regulatory or Quality position with a minimum of 2 years at a medical device company, preferably IVD.
- Strong knowledge of US FDA Quality System Regulations 21 CFR 820, ISO 13485, and EU (CE) Regulations (IVDD/IVDR).
- Proficient in quality compliance, such as CAPA, Root Cause Analysis, Validation, and Process Controls.
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.