Ansh Labs is hiring a Regulatory Affairs/Quality Assurance Specialist to implement and manage the Company’s domestic and international Regulatory Affairs (RA) procedures, and Quality Management System (QMS) procedures to support its business and release marketed In Vitro Diagnostics products ensuring adherence to established requirements to current and upcoming regulations. This position will also ensure that product and product related documents are processed in compliance with established procedures, including Change Control Orders (CCO), Device History Records (DHR), Manufacturing Work Instructions (MWI), Standard Operating Procedures (SOP), Quality System Manual (QSM), and Quality Control System (QCS).
Responsibilities include but are not limited to:
Serves as the Company Quality Management Representative, including representing the Quality Assurance department on project teams and audits.
Ensure compliance to the Company’s quality system policies and procedures.
Managing activities associated with the Company’s CAPA, complaints, and nonconformance review processes.
Coordinating management review activities and supporting internal audits.
Ensure electronic capture and retrieval of quality documents and records by reviewing, evaluating, and processing changes accurately and in a timely manner while ensuring that they meet the department goals and objectives.
Serves as the Company Regulatory Affairs representative on project teams.
Coordinates the collection of data and information for regulatory submissions; writes the required regulatory submissions for new Company products.
Performs Regulatory Affairs reviews for Company labeling change requests.
Coordinate and prepare International Dossiers with the Product Teams and disseminate the dossiers to the appropriate parties.
Bachelors/Masters in Biotech/related field.
Three plus years of experience working in a Regulatory or Quality organization with a minimum of 2 years at a medical device company, preferably IVD.
Experience with US FDA Quality System Regulations 21 CFR 820, ISO 13485, and EU (CE) Regulations (IVDD/IVDR experience is highly preferred).
Excellent understanding of US, CE and international medical device regulatory requirements.
Two or more years US, CE and international regulatory affairs experience
Premarket notification submission and 510K compliance experience.
Demonstrated communication and human relation skills.
Solid scientific analytical evaluation skills.
Ability to work well within cross-functional teams.
Ability to professionally represent company and actively participate in Regulatory and Quality System/EU Notified Body audits, e.g. FDA, ISO, EU IVDD/CE.
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.
About 445 W Medical Center Blvd, Webster, TX 77598
Ansh Labs develops and manufactures tools for biomedical research and clinical diagnostics. We serve life science researchers, physician researchers, hospitals, commercial laboratories, and public health agencies to assist with the research, diagnosis, treatment, and management of diseases. The products we develop make it possible to conduct important research in various clinical diagnostic areas.