Larcstaffing

Document Control and Regulatory Compliance Coordinator (US Citizenship

Beverly, MA, United States · Full-time

Sponsorship not specified$88k-$352kDetected 29 days ago
ComplianceFDA RegulatoryMicrosoft OfficeRegulatory Affairs

About the role

  • The clients I hire for are some of the best in the world at what they do.
  • I am honored to work with them and with the people who make them so successful!
  • Supervisory Responsibility This position has no direct reports.

Responsibilities

  • Maintain knowledge base and internal information dissemination of existing and emerging regulations, standards, or guidance documents.

Requirements

  • Candidates are required to provide proof of either US citizenship, Permanent US residency or classification as a protected individual as defined in 8 USC 1324b (a) (3).
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job, some of which may be done with accommodations.
  • While performing the duties of this job, the employee is regularly required to communicate both verbally and in writing.
  • Experience with AS9100 / ISO9001 document control quality management system.
  • Experience with writing quality and other technical procedures and forms.
  • Bachelor's degree required or equivalent experience.

Compensation

  • $88k-$352k

Benefits

  • Specific vision abilities required by this job include close vision, distance vision, color vision.

Company info

  • Assist in updating internal company applications Return Material Authorization and other Quality and Engineering applications as needed.
  • Ensure regulatory requests are submitted on the regulatory app.
  • Assist, coordinate or prepare US and international regulatory submissions.
  • Prepare or coordinate responses as requested by regulatory agencies, customers, suppliers and internal processes.
  • Reviews quality protocols to ensure appropriate collection of data to fulfill regulatory requirements.
  • Ensure all QMS procedures, work instructions (WI), forms and policies and related documents are in compliance with the QMS requirements and other Industry standards.

Equal opportunity

  • Employer/Veterans/Disabled.
  • Shareholder Preference in accordance with Public Law 88-352
  • LARC Staffing, LLC is an Equal Opportunity / Affirmative Action employer.
  • All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, national origin, disability, or protected veteran status.

Visa & Work Authorization

  • Candidates are required to provide proof of either US citizenship, Permanent US residency or classification as a protected individual as defined in 8 USC 1324b (a) (3)
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This listing is sourced directly from Larcstaffing's careers page and normalized into a canonical job model.