Regulatory Specialist

Regulatory Affairs oversees the quality system and uses a risk based approach to ensure regulatory compliance for Nelson Labs.

Department processes include function support, internal audits, external audits, agreements, change management, failure investigations and environmental monitoring, proficiency testing, quality events, supply/supplier management, corrective and preventive actions, complaints, management review, and regulatory agency interactions.

The Regulatory Specialist is primarily responsible for executing internal and external audit processes.

The Regulatory Specialist acts as the main representative of Nelson Labs during external audits to support current and potential customer's supplier management processes.

It is the Regulatory Specialist's responsibility to create an exceptional audit experience by being professional, knowledgeable and helpful to the auditor.

The Regulatory Specialist provides ongoing mentoring for NLI personnel regarding industry expectations and best practices to assist the company to be "audit ready".

The Regulatory Specialist performs internal audits as governed by FDA CFR and ISO regulations, ensuring the greatest benefit to the company by identifying non conformances and opportunities for improvement based on risk to the company.

The Regulatory Specialist provides support to functions, reviews logbooks, acts as the deputy for the Regulatory Assistant and participates in other Regulatory Affairs processes as needed.

Education and experience requirements:


* High School Diploma or equivalent and two years quality or lab experience
+ OR a B.S/A.S with one year quality or lab experience


* CQA or equivalent ASQ certification preferred

Essential job functions:

Regulatory Compliance


* Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc).


* Know and follow company policies and procedures.

External Audits


* Involve pertinent staff throughout the audit process to facilitate knowledge transfer


* Conduct a tour of the facility as requested by the auditor


* Provide necessary documents and information to the auditor as requested


* Assist with any follow up needed after the live phase of the audit


* Ensure all documents are returned to their appropriate place directly after the audit


* Prepare or complete information for written audit requests


* Prepare responses to audit reports


* Track and trend audit metrics

Internal Audits


* Conduct audits in accordance with yearly audit schedule


* Prepare audit agendas and make assignments to audit team members


* Sample items to audit based on risk to the company and failure modes of the system


* Conduct audits with a high degree of professionalism and courtesy


* Review and ensure findings are properly classified and apply the appropriate level of action necessary based on risk


* Ensure audit reports are completed, distributed, and all action items closed ...