The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Medical Device, Quality/Risk Management, Regulatory Compliance, Worldwide Regulatory Affairs
4 Year Degree
Regulatory Compliance Auditor
$80,000 -$ 88,000
Regulatory Affairs Manager
- 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
- 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
- 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. with 2+ years of regulatory auditing experience in the medical device industry
- Auditing coursework or training in the quality management system and/or relevant regulatory
- 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:
- Received 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, U.S., 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.
Minimum level of education:
Able to work in
Santa Clara, CA 95051
license or certification
Authorized to work in the following country: United States
Internal Number: 1
About Lin-Zhi International Inc
Lin-Zhi International, Inc. (LZI) is a manufacturer of in-vitro diagnostic reagents for urine and oral fluid screening for the detection of drugs of abuse. All research and development of assays are done in-house. LZI has FDA 510(k) clearance on most of the Homogeneous Enzyme Immunoassay tests that are for sale and sells the associated calibrators and controls for each test. Also available for purchase are the universal negative calibrator and Multi-Analyte calibrators and controls. The Research and Development team is currently optimizing the oral fluid enzyme immunoassays and their associated calibrators and controls, as well as working on additional urinalysis assays.