JOB DESCRIPTION

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 Compliance Auditor

RESPONSIBLE TO:

Regulatory Affairs Manager

GENERAL DUTIES:

– Lead and participate in LZI quality management system audit to ensure compliance with established regulations, standards, and requirements in the medical device industry
– Maintain compliance with regulations from different regulatory authorities such as the U.S. FDA, Health Canada, and the European Union
– Facilitating external audits from regulatory authorities, auditing organizations, and customers
     * Additional duties may be added as the need arises

SPECIFIC DUTIES:

– Conduct annual internal audits of the quality management system according to regulatory requirements from different countries and ensure process compliances to the international standards such as IVDR, ISO 13485:2016, and GMP regulatory requirements related to the medical device industry
– Gap analysis of new regulatory requirement or standards on the existing procedures
– Schedule and coordinate audit activity within the internal auditors and associate auditee department
– Verify and document evidence of compliance and non-compliance during audits and generate audit reports
– Assist with nonconformances, corrective actions, and preventative actions found from audits
– Execute procedure updates according to the opportunities for improvement found from audits via document change order(s)
– Prepare and facilitate external audits such as the FDA, ISO, and customer audits
– Participate in the annual management regulatory meeting and provide updates on the results of the internal and external audits
– Review audit reports and provide technical assistance for other audit team members
– Train new internal auditors
* Additional duties may be added as the need arises

QUALIFICATION & EXPERIENCE REQUIREMENTS:

– B.S. or M.S. in biology (or related) with 2+ years of full-time regulatory auditing experience in the medical device industry
– Advanced auditing coursework or training in the quality management system and/or relevant regulatory requirements
– Excellent writing and verbal communication skills
– Excellent attention to detail, organizational, and analytical skills
– Maintain a good working  relationship with various internal departments
– Applicants should be well-versed in the use of the internet, email, Adobe Acrobat, and the Microsoft Office suite (Word, Excel, and PowerPoint)

DESIRED EXPERIENCE & SKILLS:

– Completed Lead Auditor training for ISO 13485:2016
– Related 3rd party auditing industry management systems experience
– Working knowledge of relevant regulatory requirements for medical devices in the EU, US, Australia, Japan, Brazil, and/or Canada
– Experience implementing/auditing to ISO 13485;2016 and medical device regulatory requirements

GENERAL ON THE JOB TRAINING REQUIREMENTS:

– Team time management
– Prioritizing tasks to meet deadlines
– Multitasking abilities

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 are committed to diversity and 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.