Quality Assurance and Regulatory Affairs Specialist

Proteintech is a fast-growing Biotech company located in the greater Chicago area. Our Mission is to support our customers in all their endeavors, be it accelerating life sciences research and/or clinical diagnostics and therapies.

Proteintech is an international biotechnology company that manufactures antibodies, ELISA kits, and proteins for use in life science research. Proteintech makes all its own products to the highest standards possible, with complete control over the whole manufacturing, validation, and QC process. 200,000+ citations of Proteintech products demonstrates what matters most to the company: the success of its reagents in the hands of scientists, helping them make discoveries to change and explain the world around us. 

Position Summary:

We are seeking an experienced  Quality Assurance and Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in ISO 13485 quality management systems and experience with the registration of ASRs (Analyte Specific Reagents) and IVD (In Vitro Diagnostic) products, as well as the submission of Drug Master Files (DMFs). This role is pivotal in ensuring regulatory compliance and maintaining the highest standards of quality in our products and processes. You will work closely with cross-functional teams to support product development, manufacturing, and regulatory submissions to ensure compliance with industry standards and regulatory requirements.

Key Responsibilities:

• Regulatory Affairs:
• Lead the preparation and submission of regulatory filings for ASRs, IVD products, and DMFs to health authorities such as the FDA, EMA, and other global regulatory bodies.
• Manage the regulatory registration process for IVD products, including risk assessments, technical documentation, and post-market surveillance requirements.
• Prepare, review, and submit product registrations, including updates and renewals for ASRs, IVDs, and related products.
• Ensure regulatory compliance with global standards and provide timely regulatory advice to internal teams.
• Liaise with regulatory agencies to facilitate approvals, resolve compliance issues, and ensure timely submissions.
• Stay up to date with changes in regulatory requirements and communicate them to relevant stakeholders.
• Quality Assurance:
• Develop, implement, and maintain an effective ISO 13485 quality management system (QMS) for IVD products and ASRs, ensuring compliance with industry standards and regulatory requirements.
• Conduct internal audits and support external audits to ensure compliance with ISO 13485, FDA, and other relevant quality and regulatory standards.
• Review and approve product design, validation protocols, and test reports to ensure they meet the necessary quality standards and regulatory requirements.
• Oversee the resolution of non-conformances, CAPAs (Corrective and Preventive Actions), and quality complaints, ensuring appropriate root cause analysis and implementation of corrective actions.
• Manage the product release process, ensuring that all relevant documentation (technical files, validation reports, etc.) is accurate and compliant before products are released to the market.
• Cross-functional Collaboration:
• Work closely with R&D, Manufacturing, and Supply Chain teams to ensure regulatory and quality standards are met throughout the product lifecycle.
• Provide regulatory and quality training and support to cross-functional teams to promote a culture of compliance and continuous improvement.
• Collaborate with senior management to align regulatory strategies with company goals and timelines for product launches.
• Documentation & Reporting:
• Maintain and manage regulatory and quality documentation, ensuring that all filings, submissions, and communications with regulatory agencies are well-documented and traceable.
• Prepare and present regular reports on the status of regulatory submissions, quality audits, and compliance activities to senior management.

Preferred Education/Experience:

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field. Advanced degrees or certifications (e.g., RAC, CQE) are a plus.
• 2-3 years of experience in regulatory affairs and quality assurance in the IVD, ASR, and medical device industries.
• Experience in the registration of ASRs and IVD products, including the submission of DMFs to regulatory bodies such as the FDA and EMA.
• Experience with ISO 13485 and experience implementing and maintaining QMS in compliance with this standard.
• Strong knowledge of FDA regulations for IVD products.

Knowledge, Skills, and Abilities:

• Expertise in regulatory submission processes and technical documentation, including preparation of DMFs and technical files for IVD products.
• Proficient in ISO 13485QMS, including internal auditing, risk management, and CAPA systems.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills with the ability to interact effectively with regulatory agencies and cross-functional teams.
• Proficient in Microsoft Office Suite; familiarity with QMS software and regulatory submission tools is a plus.

Benefits:

• Paid time off
• 401K with company match
• Health and dental insurance
• Vision discount plan

Contact Katie Bellows katie@ptglab.com 

Proteintech group is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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