Regulatory Specialist (Finance)

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 prior to close of audit file
• Track and trend audit metrics

Function Support

• Maintain a quality partnership with each assigned function by performing monthly trend review, dashboard and collaborating on quality issues

Record Review

• Conduct a review of log books, as assigned, on time, and per the Log Book review SOP

Quality Metrics

• Compile/Track quality metrics in the form of dashboards and scorecards

Professional Development

• Complete required training on time (includes MasterControl tasks, on the job training, live company training, New Employee Orientation, etc.)

Perform other duties as assigned.

Job requirements:

• Demonstrate some knowledge of GMP, GLP, and ISO 17025 regulatory requirements
• Attention to detail
• Ability to effectively work with and support customers, members of staff and management with professional courtesy
• Ability to accept constructive criticism and to implement and learn quickly from feedback
• Ability to prioritize tasks and consistently meet deadlines
• Demonstrate knowledge of trend analysis to identify and act on recurring issues
• Ability to be proactive in continuous improvement of systems, processes, and procedures
• Must be solution driven and seek input from others to make decisions
• Must have excellent response times and service for internal and external customers
• Ability to communicate internally and externally in a clear and objective manner
• Professional and helpful attitude
• Dependability in hosting audits as scheduled and until audit is complete
• Proficient in Microsoft programs and typing.

Physical requirements:

Must be able to spend 30-40% standing and walking the lab on audit days and 10% on non-audit days. Must be able to sit 60-70% on audit days and 90% on non-audit days and 50% on the computer on audit days and 90% on the computer on non-audit days. Also, must be able to lift a minimum of 20lbs.The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.

Sotera Health goes to market through its three best-in-class businesses - Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about Sotera Health at soterahealth.com.