The nature of LIN-ZHI INTERNATIONAL’s business dictates that personnel must remain flexible with the ability to accept responsibilities within their educational  and training levels. These may be different from those stated on their ‘Terms of
Employment’.

JOB TITLE:
Regulatory Affairs Associate/Technical Support Associate

RESPONSIBLE TO:
Regulatory Affairs Manager/VP of Operations

GENERAL DUTIES:
‐Responsible for International Organization for Standardization (ISO) system
‐Responsible for obtaining and maintaining compliance to regulations from different regulatory authorities such as the U.S. FDA, Health Canada, and the European Union.
‐Responsible for performing internal audits and facilitating external audits
-Customer technical support
* Additional duties may be added as the need arises

SPECIFIC DUTIES:
Regulatory Affairs Associate
-Maintain document control, certifications, and standards
‐Handle complaints, nonconformances, CAPAs
‐Perform internal audits to ensure that SOPs are followed
‐Facilitate external audits such as the FDA, ISO, and customer audits
‐New device registration
 ‐Create and update Bartender labels
 * Additional duties may be added as the need arises

Technical Support Associate:
– Customer Complaint Handling (intake of customer complaint, testing and investigation of product issues)
-Assay and Parameter Troubleshooting
-Distribution of product information/ information requests (product catalog, product insert, parameter sheet, cross-reactivity information) to customers
-Assist in the update of Engineering Change Orders (ECOs) that involve changes to product inserts and parameter sheets
-Cross-reactivity record maintenance
-Run retain tests
-New employee technology presentation
‐ Coordinating product samples with the Production Team for bids
‐ Generating bid protocols/procedures
* Additional duties may be added as the need arises.

QUALIFICATION & EXPERIENCE REQUIREMENTS:
M.S. Or B.S. in the area of biology (or relevant scientific discipline)
‐Receive a degree or a certificate from a certified regulatory affairs program or have at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
‐Applicants should be well-versed in the use of the internet/e-mail, Adobe Acrobat, Microsoft Word, Excel, and PowerPoint programs
‐Applicant should have a high attention to detail and ability to work well under deadline situation
 ‐Excellent written and verbal communication skills
 ‐Ability to work well in a team

Lin-Zhi International, Inc. is committed to building a diverse and inclusive work environment that reflects the society and communities in which we are located. We’re committed to diversityand actively seek out applicants from groups facing systemic inequities in the biotech world.

Lin-Zhi International, Inc. is an equal opportunity employer. We enthusiastically welcome and accept our responsibility to make employment decisions without regard to race, gender, sex, sexual orientation, gender identity, age, religious creed, color, national origin, religion, marital, status, medical condition as defined under State law, disability, genetic information, military service, pregnancy, childbirth and related medical conditions or any other classification protected by federal, state, and/or local laws and ordinances.