Careers
REGULATORY AFFAIRS & QUALITY ASSURANCE MANAGER
SUMMARY
Ansh 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 DUTIES
Quality System Management
- Oversee 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 98/79 EC, IVDR 2017/746, 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, 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, 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 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. 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 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.
- 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 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.
- Conduct risk analysis/assessments 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 Support
- Train 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.
QUALIFICATIONS
- Bachelors/Masters in Biotechnology/related field (life sciences, biotech engineering, chemistry).
- Eligible to work in the USA without VISA sponsorship.
EXPERIENCE
- 5+ 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 (IVDD/IVDR) 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.
Interested Candidates are encouraged to submit their resume/cv to: Careers@AnshLabs.com
PROTEIN BIOCHEMIST
SUMMARY
Ansh Labs is looking for a highly motivated, hands-on Scientist to help lead the Protein Biochemistry team. This position will primarily be responsible for protein design, method development, scaleup, characterization, product application and providing detailed information for writing point-of-sale documents. As a key member of the Research & Development and Manufacturing teams, this individual will provide critical scientific skills to generate novel research tools for the diagnostics and therapeutics markets.
ESSENTIAL JOB DUTIES
- Design and develop stable recombinant antigens to express in various expression systems such as mammalian cells (CHO/HEK) or bacteria (E.coli).
- Optimize expression conditions to maximize yield, quality, and functionality of proteins
- Develop and implement purification strategies/protocols (affinity chromatography) for recombinant antigens.
- Able to scale up protein production processes from lab-scale to large-scale production runs.
- Perform process optimization and validation to ensure consistency and reproducibility.
- Identify and troubleshoot issues related to protein expression, solubility, purification, and stability.
- Conduct stability studies to assess protein quality and functionality over time.
- Perform analysis and characterization of proteins (western blot, IF, IHC, ELISA, etc.).
- Perform protein conjugations (Enzymes, fluorescent dye, etc.).
- Develop, validate, and document protein assays, bioassays.
- Manage the maintenance and troubleshooting of instrumentation in the protein chemistry lab.
- Work cross-functional.
- Planning, conducting, analyzing results, and use of Lab Notebook to document experiments.
- Summarize and report data and method development efforts and present work in collaborative meetings with other R&D groups.
- Perform additional laboratory duties as required to support R&D and company projects.
- Display strong teamwork skills as part of the development and production team to ensure effective communication in a multi-functional team setting.
- Position may require travel to customer sites and conferences in North America.
QUALIFICATIONS
- PhD in Biochemistry, Microbiology, Biotechnology, Chemistry or a related field with 0-2 years’ experience, MS with 6+ years’ experience, or BS with 8+ years’ experience.
- Strong background in protein design and production (3+ years).
- 2+ years’ experience in protein purification/separation and characterization.
- Experience with enzymology and kinetics measurements is a plus.
- Eligible to work in the USA without VISA sponsorship.
SKILLS
- Ability to recognize unusual results and troubleshoot testing problems.
- Ability to write, review, update and follow SOPs (standard operating procedures).
- Ability to carry out aseptic work.
- Capable of evaluating, interpreting, and reporting test results.
- Experience using Microsoft Office applications including Word, Outlook, PowerPoint and Excel.
- Excellent written and oral communication skills.
Interested Candidates are encouraged to submit their resume/cv to: Careers@AnshLabs.com
SCIENTIST
SUMMARY:
As a key member of the Manufacturing or R&D Department, this individual will provide critical scientific skills to assist in the development and scale-up of immunodiagnostic products on various platforms (microtiter based ELISA, magnetic particle based immunoassays, routine microbiology, biochemistry, and protein purification.
ESSENTIAL JOB DUTIES:
- Design and Development of novel immunoassays on multiple platforms.
- Planning, conducting, analyzing results, and use of Lab Notebook to document experiments.
- Manufacturing and scale-up of immunoassay reagents.
- Routine ELISA and CLIA development techniques.
- Good laboratory practices and basic knowledge to handle biologicals and chemicals.
- Demonstrate strong organizational skills to ensure thorough information tracking in material management systems associated with development and production.
- Display strong teamwork skills as part of the development and production team to ensure effective communication in a multi-functional team setting.
- Position may require travel to customer sites and conference in North America.
QUALIFICATIONS:
- Master’s degree in Biological/Chemical Sciences/Biotechnology or related area with 1 year of experience. -OR- Bachelor’s degree in Biological/Chemical Sciences/Biotechnology or related area with at least 5 years of experience.
- Eligible to work in the USA without VISA sponsorship.
EXPERIENCE:
- Requires one or more years of experience in immunoassay development, immunodiagnostic lab testing and manufacturing of biological reagents.
SKILLS:
- Ability to recognize unusual results and troubleshoot testing problems.
- Ability to write, review, update and follow SOPs (standard operating procedures).
- Ability to carry out aseptic work.
- Capable of evaluating, interpreting, and reporting test results.
- Experience using Microsoft Office applications including Word, Outlook, Visio, PowerPoint and Excel.
- Excellent written and oral communication skills.
Interested Candidates are encouraged to submit their resume/cv to: Careers@AnshLabs.com