Compliance Manager
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Job Description
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.
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.
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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