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Regulatory Quality Specialist

2 months ago

Woodland, California, United States JobRialto Full time
Position Overview:

As a Regulatory Quality Specialist at JobRialto, you will play a crucial role in ensuring that our products and processes comply with the latest regulations and standards. Your expertise will help maintain the integrity of our quality management systems and support our commitment to excellence in the industry.

Key Responsibilities:

Daily Duties:

- Ensure adherence to evolving regulations impacting products and processes, including Quality System Regulations and global import/export guidelines.

- Oversee the setup of new products and manage associated projects effectively.

- Assist in conducting supplier audits as necessary.

- Maintain and file BSE Serum Certificates of Suitability with relevant authorities.

- Collaborate with regulatory bodies on compliance activities, including approvals, import/export regulations, traceability, and safety testing.

- Act as a resource for customer inquiries regarding regulatory and technical matters.

- Maintain an ISO 13485-based quality management system.

- Implement and manage Corrective and Preventive Actions (CAPA) and facilitate problem resolution.

- Lead the coordination of Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition.

- Review and revise procedures, specifications, and forms to enhance the Quality Management System (QMS).

- Serve as the primary contact for Quality Help Desk and customer complaints, including managing questionnaires and surveys.

- Conduct internal audits to ensure compliance with internal requirements and standards.

- Support customer quality audits, supplier quality audits, and regulatory inspections.

- Perform investigations and analyses to resolve quality-related issues.

- Collaborate with various teams to facilitate the implementation of quality systems.

- Create new product master files that meet customer and quality system requirements.

- Uphold quality standards by adhering to company policies and procedures, focusing on product performance and quality verification.

- Identify, document, and investigate issues related to products, processes, and quality systems.

- Evaluate processes for potential improvements and standardization, initiating actions to prevent non-conformance.

- Provide training on quality systems and applicable regulations as determined by your supervisor.

- Track and trend aspects of the QMS.

Additional Responsibilities:

- Travel Requirements:
Less than 10%

- Work Schedule:
Standard business hours, Monday - Friday

Required Education:

- A minimum of a Bachelor's degree in Science, Engineering, Bioengineering, or a related field is required.

- Preference will be given to candidates with degrees in Chemistry or Biology.

Preferred Experience:

- At least 3 years of experience in Quality or Regulatory roles, ideally within the medical device, pharmaceutical, or biotechnology sectors.

Essential Skills:

- In-depth knowledge and practical application of Quality Systems Regulations (21 CFR 820) and ISO 13485.

- Ability to develop, update, and train staff on Standard Operating Procedures (SOPs).

- Familiarity with ISO standards and Quality Management Systems (QMS).

- Proficient in problem-solving techniques for investigations and root cause analysis.

- Experience conducting internal and external audits.

- Capability to monitor the QMS, including Change Control, CAPA, Complaints, and Nonconforming Materials.

- Experience with Continuous Improvement methodologies, Lean, or Six Sigma.

Desirable Qualifications:

- Familiarity with SAP, EtQ, and/or PeopleSoft.

- Experience in statistical analysis and project management.

- Knowledge of animal by-product import/export regulations.

- Understanding of animal health, virology, immunology, and epidemiology.

Soft Skills:

- Strong organizational skills with the ability to manage multiple tasks.

- Excellent interpersonal and communication abilities.

- Effective time management skills and keen attention to detail.

- Ability to influence and collaborate with team members across functional areas.

- Capacity to work independently with minimal supervision.

Education Requirement:
Bachelor's Degree.