ARC-One Solutions logo
ARC-One Solutions

Saving lives by providing market-leading blood supply solutions.

Compliance Manager

ComplianceComplianceFull TimeRemoteSeniorTeam 51-200Since 2020H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

29 days ago

Salary

$104.9K - $164.9K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Compliance Manager

ARC-One Solutions

• Oversees the planning, execution, and monitoring of quality and regulatory activities to ensure organizational compliance • Leads and develops a high‑performing compliance team by setting priorities, managing performance to activity, and supporting professional development • Serves as the quality knowledge expert in all related to a SaMD organization and the primary point of contact for the Agile Release Train (ART) and Compliance Teams • Works collaboratively with the ART and management team members to align quality and compliance activities with business and product goals • Promotes Lean-Agile product development principles integrates them into the Quality Management System using a risk-based approach • Identifies, assesses, and communicates quality and compliance risks, providing actionable recommendations to improve product quality and regulatory readiness • Drives continuous improvement initiatives to maintain adherence to Standard Operating Procedures (SOPs), regulatory requirements, and quality standards • Leads the creation, review, approval, and maintenance of quality documentation • Plans and manages quality management projects that support ongoing compliance and continuous improvement • Establishes, monitors, and reports on post-market quality metrics • Manages the internal audit program, guiding internal auditors and ensuring overall organizational compliance • Facilitates external audits and inspections, including Food and Drug Administration (FDA), client, and other regulatory audits, to ensure successful outcomes • Ensures execution of regulatory operations, including standards maintenance, product labeling, Unique Device Identifier (UDI) updates, and medical device reporting requirements.

Job Requirements

  • Bachelor’s degree in science, information systems, business or related field from an accredited college or university
  • Minimum of five (5) years of experience in Quality and/or Regulatory Affairs, including experience with FDA and other regulatory agencies, software development teams, and release management
  • ASQ Certified Quality Auditor (CQA) and/or Certified Manager of Quality/Organizational Excellence (CMQ/OE) certification preferred
  • Scaled Agile Framework (SAFe) Agile certification preferred
  • Extensive knowledge of FDA Quality Management System Regulation (QMSR) and ISO 13485 standards
  • Working knowledge of ISO 14971 (Risk Management) and IEC 62304 (Medical Device Software) preferred
  • Ability to translate complex quality and regulatory concepts into clear, non‑technical guidance for ART and management teams
  • Demonstrated knowledge of Agile software development lifecycle principles
  • Ability to identify and remove impediments and evolve systems and practices in support of Lean-Agile product development; skilled in problem solving and analytics
  • Ability to provide career coaching and support individual professional development
  • Ability to listen and support individuals in problem identification, root cause analysis, and decision-making
  • Ability to manage multiple priorities and remain adaptable in a changing work environment
  • Ability to communicate effectively, both verbally and in writing
  • Ability to travel up to 20% of the time.

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