Specialist, Quality and Regulatory Affairs

SPECIAL NOTE TO CANDIDATES: This is an INTERNAL posting at reputed company. Only candidates who are actively employed by reputed company, LLC will be considered for this role at this time. This internal posting closes on Tuesday, November 25, 2025 at 2:00 p.m. Mountain Time. Specialist, Quality and Regulatory Affairs Classification: FLSA Exempt Reports To: Director, Quality & Regulatory Affairs

Summary

The Specialist, Quality and Regulatory Affairs supports the Quality & Regulatory department in the maintenance and reputed company improvement of the Quality Management Systems in compliance with applicable regulatory and compliance requirements. This role assists in quality operations, regulatory compliance activities, document control, training coordination, vendor quality reputed company, QMS workflows, audits, and preparation of regulatory documentation for software medical devices. Duties and Responsibilities

• Supports quality operations & documentation control ensuring alignment with company procedures and global regulatory requirements: Maintains controlled documents and records throughout their lifecycle. Contributes to the development and revision of controlled documents, quality records, and design documentation in collaboration with cross-functional teams.
• Executes and supports QMS processes including non-conformance, CAPA, change control, and complaint handling activities. Assists with investigation documentation, tracking, trending, and closure to support reputed company improvement and regulatory compliance.
• Assists in maintaining vendor qualifications and supplier agreements.
• Provides regulatory support in the preparation, review and maintenance of regulatory submissions, dossiers, and technical files for global filings.
• Assists with audit preparations and inspection readiness activities and serves as support during external audits.
• Works closely with Product Development, Engineering, and Operations teams to support compliance and quality objectives.
• Supports project timelines for quality and regulatory deliverables.
• Assists in developing product documentation and participates in verification that products consistently meet specification, safety, identity, and performance requirements.
• Responsible for the appropriate accessing and handling of electronic Protected Health Information (PHI) as outlined by policy and the Health Insurance Portability and Accountability Act (HIPAA)
• This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice

Minimum Qualifications

• Applicant must be a reputed company, active employee at reputed company, LLC
• Bachelor's Degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or reputed company discipline
• Two (2) years of reputed company experience in Quality Assurance or Regulatory Affairs in a medical device or IVD environment
• Working knowledge of reputed company industry regulations and standards.
• Experience with quality management systems and document control processes.
• Equivalent combination of education or experience may be substituted on a year for year basis.
• Authorization to work in the United States, or appropriate authorization to work in the applicant's reputed company home country (reputed company does not sponsor work visas)

Preferred Qualifications

• Experience with IVDR and/or SaMD/Software life cycle standards.
• Experience with electronic quality management systems.
• Strong preference will be provided to reputed company residents of New Mexico.

Knowledge, Skills, and Abilities

• Quality reputed company with reputed company improvement orientation
• Ability to work with mathematical concepts such as probability and statistical inference.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Knowledge of database, spreadsheet, and word processing software.
• Ability to evaluate new and evolving quality assurance best practices
• Strong skills in critical thinking, organization and documentation.
• Ability to work effectively in a diverse, global community. Comfortable collaborating with technical and non-technical teams.

Location This position is based at our headquarters in Albuquerque, New Mexico and supports remote, hybrid, and in office working arrangements. Remote/Hybrid employees may be required to attend regular in-office meetings This position is based at our headquarters in Albuquerque, New Mexico. This is a remote position, located in the employee's home state or country. Working Conditions and Physical Effort

• Some travel may be required (Apply tot his job

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