The Staff IVDR Compliance Specialist is responsible for establishing and maintaining effective structures to ensure alignment of EU IVDR and ISO 13485 standards with the quality systems at Twist Bioscience. Create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidances and standards.
What You’ll Be Doing
- Analyze and refine end-to-end business processes to integrate IVDR into QMS requirements
- Collaborate with cross-functional teams to address QMS noncompliance and develop remediation plans
- Identify interlinkages & cross-site dependencies in business processes; ensure identified linkages, dependencies and risks are seamlessly managed in detailed project plans
- As needed, QA representative on Core Teams for FDA regulated products
- Define the requirements to establish a, “Best-in-Class” cGMP workflow to manufacture IVD products
- Collaborate with Head of Quality to define requirements for implementing IVDR, Harmonized Standards, and guidance from Competent Authorities & Notified Bodies
- Generate, edit, and maintain QMS documentation, including but not limited to, global/departmental policies, procedures, work instructions, forms, templates, and training materials
- Develop Post Market Surveillance and Risk Management Plans to align with IVDR and IVD requirements
- Collaborate with IT and Software Development to advise on IVDR Gaps as they relate to Manufacturing Execution Systems and eCommerce Platforms
- Collaborate with the development of Technical Documentation for EU IVDR submission
What You’ll Bring to the Team
- Bachelor's degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline (Biomedical Engineering, or other related engineering field) or related field, or equivalent combination of education and work-related experience.
- 9+ years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience
- Knowledge of good manufacturing practices
- Solid understanding of EU IVDR and USA IVD Regulations
- Solid understanding of ISO 14971, ISO 13485, 21 CFR 820, Global Harmonization Task Force for Medical Devices (IMDRF)
- Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience) required
- Experience with document management systems required
- Advanced Degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline (Biomedical Engineering, or other related engineering field) or related field
- Experience with Atlassian Confluence and JIRA
- Comprehensive knowledge and application business concepts, procedures and practices
- Knowledge of Product Lifecycle Management
- Experience working in in-vitro diagnostic manufacturing
- Ability to work independently and lead and mentor others required
- Demonstrated strong attention to detail and “do it right the first time” attitude required
- Good judgment and decision-making skills are required (knows how to make trade-off decisions while balancing compliance and business impact)
- Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands is required
- Experience with Design Quality responsibilities preferred
About Twist Bioscience
Twist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.
At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.
Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.