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Serialization Specialist Jobs (NOW HIRING)

Sonsoft Inc

SAP Service Module specialist

Schofield, WI · On-site

Experience in Equipment Master, Warranty master and serialization of Material Master data. Qualifications Well versed with SAP configuration of Service Management and understanding of standard best ...

Merck Group

Channel Operations Specialist

Boston, MA · On-site

$36 - $55/hr

Advanced understanding of order-to-cash, serialization, and distribution * Ability to communicate openly and share information to foster trust while encouraging constructive debate, making informed ...

Leidos

Inventory Specialist

Huntsville, AL · On-site

$35K - $64K/yr

Leidos Defense Systems Electrical Manufacturing is seeking an Inventory Specialist to join our team ... Component serialization/marking. * Supporting materials audits, material handling, and maintaining ...

Leidos

Inventory Specialist

Huntsville, AL · On-site

$35K - $64K/yr

Leidos Defense Systems Electrical Manufacturing is seeking an Inventory Specialist to join our team ... Component serialization/marking. * Supporting materials audits, material handling, and maintaining ...

Leidos

Inventory Specialist

Huntsville, AL

$35K - $64K/yr

Leidos Defense Systems Electrical Manufacturing is seeking an Inventory Specialist to join our team ... Component serialization/marking. * Supporting materials audits, material handling, and maintaining ...

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Serialization Specialist information

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$22.5K

$76.5K

$110.5K

How much do serialization specialist jobs pay per year?

As of Jun 7, 2026, the average yearly pay for serialization specialist in the United States is $76,465.00, according to ZipRecruiter salary data. Most workers in this role earn between $57,000.00 and $98,500.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Serialization Specialist, and why are they important?

To thrive as a Serialization Specialist, you need in-depth knowledge of pharmaceutical supply chain processes, regulatory compliance (such as DSCSA and EU FMD), and a relevant technical or scientific degree. Familiarity with serialization software (e.g., SAP ATTP, TraceLink), barcode systems, and data management tools is typically required. Strong analytical thinking, attention to detail, and effective communication skills help ensure accuracy and collaboration across departments. These skills are crucial for maintaining regulatory compliance, ensuring product traceability, and safeguarding patient safety in pharmaceutical distribution.

What are Serialization Specialists?

Serialization Specialists are professionals responsible for ensuring that products, especially in the pharmaceutical and food industries, are properly serialized and tracked through the supply chain. They implement and manage systems that assign unique identifiers to products, which helps prevent counterfeiting, ensures regulatory compliance, and improves traceability. Their work often involves working with specialized software, coordinating with production teams, and maintaining compliance with government regulations related to serialization. Serialization Specialists play a key role in product safety and supply chain integrity.

What are some common challenges faced by Serialization Specialists when implementing serialization systems in pharmaceutical manufacturing?

Serialization Specialists often encounter challenges such as integrating new serialization software with existing manufacturing execution systems, ensuring data accuracy across multiple packaging lines, and maintaining compliance with evolving global regulations. They must also coordinate closely with quality assurance, IT, and supply chain teams to troubleshoot issues and implement process improvements. Staying updated on regulatory requirements and adapting serialization solutions to meet diverse market needs are key aspects of the role.
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What cities are hiring for Serialization Specialist jobs? Cities with the most Serialization Specialist job openings:
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Serialization Specialist jobs near you
Infographic showing various Serialization Specialist job openings in the United States as of May 2026, with employment types broken down into 20% Locum Tenens, 27% As Needed, 13% Full Time, 33% Temporary, and 7% Nights. Highlights an 88% Physical, 2% Hybrid, and 10% Remote job distribution, with an average salary of $76,465 per year, or $36.8 per hour.
Regulatory Affairs Specialist II - Sarnova - Dublin, OH

Regulatory Affairs Specialist II - Sarnova - Dublin, OH

Sarnova HC, LLC

Dublin, OH • On-site

Full-time

Retirement

Posted 20 days ago

Sarnova rating

8.2

Company rating: 8.2 out of 10

Based on 8 frontline employees who took The Breakroom Quiz

Job description

Sarnova is the leading national specialty distributor of health care products in Emergency Medical Services (EMS) and Respiratory Markets and is the industry leader in Revenue Cycle Management within Emergency Medical Services (EMS). The company operates through several market-leading companies including Tri-anim Health Services, the largest specialty distributor of respiratory products, Bound Tree Medical, the largest supplier of EMS products, EMP and Cardio Partners, a full Sudden Cardiac Arrest Solution provider, and Digitech, the leader in EMS revenue cycle management.
Hybrid Schedule: M-Th in office, Fri work from home
Summary:
The Regulatory Affairs Specialist II serves as a high impact individual contributor responsible for driving the Company's compliance with applicable federal, state, and international laws and regulations governing medical devices, pharmaceutical products, and other regulated healthcare products distributed by the Company. This role owns regulatory execution, including product classification, labeling and claims review, post-market surveillance, distribution compliance, and regulatory risk monitoring to ensure products are legally marketed and maintained throughout their lifecycle.
The Specialist II acts as a regulatory subject matter expert and trusted advisor to cross-functional partners, proactively identifying risk, implementing controls, and leading corrective actions to protect the Company from enforcement exposure while enabling compliant commercial growth.
Organizational Impact:
As a Regulatory Affairs Specialist II, you will play a critical role in protecting the Company from regulatory and enforcement risk while enabling compliant commercialization and distribution of regulated products. Your work will directly support audit readiness, regulatory inspections, and the Company's reputation with regulators, customers, and business partners.
Essential Duties and Responsibilities:
Regulatory Strategy& Product Governance
  • Lead regulatory classification and product determination activities, including medical device
    class (I, II, III), OTC vs. prescription status, combination product evaluation, and applicable
    regulatory pathways
  • Assist with FDA establishment registration and product listing activities, including UDI
    compliance, GUDID submissions, and NDC assignments where applicable
  • Maintain defensible regulatory rationale files for audit and inspection readiness

Supplier & Manufacturer Oversight
  • Lead regulatory due diligence for new manufacturers, contract manufacturers, and suppliers
  • Conduct regulatory audits and document findings with clear risk assessments and corrective
    action expectations
  • Qualify suppliers, including monitoring ongoing compliance of foreign and domestic
    manufacturers
  • Escalate and manage regulatory nonconformances to resolution

Labeling, IFUs & Claims Review
  • Serve as primary regulatory reviewer for product labeling to ensure compliance with FDA
    regulations (21 CFR 801 and 201), including UDI, instructions for use, contraindications,
    warnings, and required statements
  • Review promotional materials, websites, distributor sales sheets, training materials, and social
    media content for regulatory and FTC compliance
  • Participate in medical/legal/regulatory (MLR) review committee governance and claims
    substantiation file review
  • Identify, mitigate, and escalate off-label promotion risk, recognizing labeling and claims review
    as a high-enforcement-exposure area

Post-Market Surveillance & Complaints:
  • Conduct post-market surveillance activities, including Medical Device Reporting (MDR)
    compliance under 21 CFR 803
  • Manage or support the investigation, documentation, and resolution of product complaints and
    adverse events
  • Identify and trend regulatory and quality issues reported by customers, sales teams, and
    operations
  • Partner with Quality and Operations to implement corrective and preventive actions

Distribution, Import & Export Compliance:
  • Lead compliance execution for the Drug Supply Chain Security Act (DSCSA), including
    serialization, transaction data exchange, and authorized trading partner verification
  • Review import and export compliance activities, including customs classification, FDA import
    hold management, and foreign manufacturer verification
  • Manage FDA import holds and recommend resolution strategies
  • Monitor and manage internal controls governing international shipment eligibility
  • Ensure distribution practices align with regulatory restrictions

Regulatory Intelligence & Risk Monitoring
  • Monitor FDA warning letters, enforcement actions, and competitor regulatory trends
  • Track regulatory changes and assess impact to existing and future products
  • Prepare for and participate in internal audits, audit defense, and inspection readiness and
    collaborate cross-functionally to implement corrective actions and process improvements
  • Develop and maintain regulatory review standard operating procedures and documentation
    frameworks

Additional Responsibilities:
  • Support corporate regulatory and compliance goals and related KPIs
  • Manage or contribute to special regulatory projects as assigned
  • Perform additional duties as assigned

Skills/Experience Required:
  • Education: Bachelor's degree required
  • Minimum of 5 years of progressive quality or regulatory experience in the medical device,
    pharmaceutical industry or life sciences industry
  • Demonstrated familiarity with FDA, state regulations, and ISO 13485
  • Strong individual accountability and ethics: acts with integrity and takes ownership for attitude,
    behavior and outcomes
  • Ability to interact and communicate professionally and effectively with internal and external
    customers including regulatory agencies
  • Strong written and verbal communication skills
  • Well-developed organizational and cross functional skills
  • Computer skills to include Microsoft Office applications, with emphasis in database and spreadsheet software

Skills/Experience Preferred:
  • Regulatory Affairs Certification
  • Blood/biologics experience (BLA familiarity, 21 CFR 600-680, blood establishment registration)
  • Manufacturing regulatory experience
  • Experience responding to audit or regulatory inspections

Sarnova is an Equal Opportunity Employer. We offer a competitive salary, commensurate with experience, along with a comprehensive benefits package, including 401(k) Plan. EEO/M/F/Veterans/Disabled. Our mission is to be the best partner for those who save and improve patients' lives. Excellence in delivering upon our mission is dependent upon having a diverse team that is empowered to bring their full, authentic self to work each day. We strive to create a workplace that reflects the communities we serve, and we are passionate about creating an inclusive workplace that promotes and values diversity.
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