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.