Manager of Compliance
Overview
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. The base salary range for this position is $104,934-$164,897. Actual pay will be determined based upon a candidate’s job-related knowledge, skills, education, experience, geographic location, and may include other job-related factors such as certification(s), professional licensure, or internal equity considerations.
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.
Qualifications
Required Qualifications 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. Working Conditions: Flexible work hours in a fun collaborative environment Must have reliable internet connection at all times Must have the ability to travel, as needed for company meetings. Apply To This Job