Manager of Compliance

ARC-One Solutions

20h•Hybrid

About The Position

Oversees the execution of quality and regulatory activities for a Software as a Medical Device (SaMD) organization, ensuring compliance with applicable regulations and integrating ARC‑One’s Lean‑Agile framework into the Quality Management System. Serves as a subject matter expert and leader in quality and regulatory affairs, guiding the compliance team and collaborating with executive leadership and senior management to achieve organizational quality, compliance, and continuous improvement objectives.

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
Extensive knowledge of FDA Quality Management System Regulation (QMSR) and ISO 13485 standards
Demonstrated knowledge of Agile software development lifecycle principles
Ability to translate complex quality and regulatory concepts into clear, non‑technical guidance for ART and management teams
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
Must have reliable internet connection at all times

Nice To Haves

ASQ Certified Quality Auditor (CQA) and/or Certified Manager of Quality/Organizational Excellence (CMQ/OE) certification preferred
Scaled Agile Framework (SAFe) Agile certification preferred
Working knowledge of ISO 14971 (Risk Management) and IEC 62304 (Medical Device Software) preferred

Responsibilities

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.