Compliance Manager

ARC-One Solutions

Manager of Compliance overseeing quality and regulatory activities for a Software as a Medical Device organization. Leading a compliance team and ensuring adherence to various regulations and standards.

Posted 4/30/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $104,934 - $164,897 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account ARC-One Solutions Website LinkedIn All Job Openings 51 - 200 employees Founded 2020 ⚕️ Healthcare Insurance 💊 Pharmaceuticals Healthcare Insurance
Software
Pharmaceuticals ARC-One Solutions is creating a next-generation Blood Establishment Computer Software (BECS) platform designed to support safe, efficient, and compliant regulated blood supply chain management. Formed through a partnership between two of the largest blood centers in the country, ARC-One Solutions plays a crucial role in fulfilling over 50% of the nation’s blood supply needs. With a focus on quality and compliance, their software provides robust solutions for blood collection, manufacturing, and distribution management, ultimately contributing to saving lives. Compliance Manager Job not on LinkedIn 🔥 4 minutes ago 🇺🇸 United States – Remote 💵 $104.9k - $164.9k / year ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance Apply Now Find Hiring Managers Customize resume for this job Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
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. 🎯 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. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Compliance Generalist 🔥 34 minutes ago XYPN 51 - 200 Website LinkedIn All Job Openings Compliance Generalist supporting compliance operations at SEC-registered investment adviser managing $1B in assets. Engaging in compliance policies and developing systems as needed. 🇺🇸 United States – Remote 💵 $72k - $93.6k / year ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance Senior GRC Analyst 🔥 1 hour ago Juniper Square 201 - 500 💸 Finance 🏠 Real Estate ☁️ SaaS Website LinkedIn All Job Openings Senior GRC Analyst responsible for governance, risk management, and compliance at Juniper Square. Handling compliance certifications, risk registers, and cross-functional team collaboration efficiently. 🇺🇸 United States – Remote 💵 $135k - $190k / year 💰 $75M Series C on 2019-11 ⏰ Full Time 🟠 Senior 🚔 Compliance Compliance Coordinator 🔥 1 hour ago MedCerts 51 - 200 📚 Education ⚕️ Healthcare Insurance Website LinkedIn All Job Openings Regulatory and Compliance Coordinator assisting Stride Inc. with grants and contracts activities. Responsible for compliance reporting, submissions, and archival activities related to workforce investments. 🇺🇸 United States – Remote 💵 $50k - $65k / year 💰 Venture Round on 2016-03 ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance Compliance Coordinator 🔥 2 hours ago Stride, Inc. 5001 - 10000 📚 Education 🛍️ eCommerce ☁️ SaaS Website LinkedIn All Job Openings Regulatory and Compliance Coordinator managing the submission and compliance of grants and contracts for an online training provider. Assisting in multiple regulatory activities and supporting compliance reporting deadlines. 🇺🇸 United States – Remote 💵 $50k - $65k / year ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance Regulatory Affairs Specialist 🔥 4 hours ago Cook Group 11 - 50 ⚕️ Healthcare Insurance 🧬 Biotechnology Website LinkedIn All Job Openings Regulatory Affairs Specialist working at Cook Inc. in Bloomington, IN. Ensuring timely product approvals and regulatory compliance through effective communication and collaboration. 🇺🇸 United States – Remote ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance View More Compliance Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

Quality Management System (QMS)Regulatory AffairsRisk ManagementAgile software development lifecycleContinuous improvementQuality documentationPost-market quality metricsInternal audit programExternal auditsMedical device reporting

Soft Skills

LeadershipProblem solvingAnalytical skillsCommunicationCoachingAdaptabilityCollaborationPrioritizationDecision-makingSupportive listening

Certifications

Bachelor's degreeASQ Certified Quality Auditor (CQA)Certified Manager of Quality/Organizational Excellence (CMQ/OE)Scaled Agile Framework (SAFe) Agile certification