Job Description
Team: Legal
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Manager of Compliance in the United States.
This role is a key leadership position within a Software as a Medical Device (SaMD) environment, responsible for ensuring robust quality and regulatory compliance across the organization. You will oversee the execution of compliance activities while integrating Lean-Agile principles into the Quality Management System to support continuous improvement and product excellence. Acting as a subject matter expert, you will guide cross-functional teams, including Agile Release Trains and senior leadership, to align regulatory requirements with business and product development goals. The position combines strategic oversight with hands-on regulatory leadership, including audit management, risk assessment, and quality system governance. You will play a central role in ensuring FDA and international compliance while enabling scalable, agile-driven development practices. This is a high-impact role where your expertise directly influences product safety, regulatory readiness, and organizational quality maturity. You will also contribute to building a strong culture of accountability, coaching, and continuous improvement.
Accountabilities:
- Lead and oversee all quality and regulatory compliance activities, ensuring adherence to FDA, ISO, and applicable global regulatory standards.
- Manage and develop a high-performing compliance team, including performance management, coaching, and professional growth support.
- Serve as the primary quality and compliance subject matter expert for SaMD operations and Agile Release Train (ART) teams.
- Integrate Lean-Agile principles into the Quality Management System using a risk-based approach to improve product development outcomes.
- Identify, assess, and communicate compliance risks, providing actionable recommendations to leadership and development teams.
- Lead internal audit programs and coordinate external audits and regulatory inspections, including FDA and client audits.
- Oversee the creation, maintenance, and approval of quality and regulatory documentation and systems.
- Establish and monitor post-market quality metrics to ensure ongoing compliance and performance visibility.
- Drive continuous improvement initiatives to enhance SOP adherence, regulatory readiness, and operational efficiency.
- Manage regulatory operations such as labeling updates, UDI compliance, standards maintenance, and medical device reporting.
- Bachelor’s degree in Science, Information Systems, Business, or a related field.
- Minimum of 5+ years of experience in Quality and/or Regulatory Affairs within FDA-regulated or medical device environments.
- Strong knowledge of FDA Quality Management System Regulation (QMSR) and ISO 13485 standards.
- Familiarity with ISO 14971 (Risk Management) and IEC 62304 (Medical Device Software) standards.
- Experience working with Agile software development teams and release management processes.
- Strong leadership experience, with the ability to manage, coach, and develop teams.
- Ability to translate complex regulatory concepts into clear, actionable guidance for technical and non-technical stakeholders.
- Strong analytical, problem-solving, and risk assessment skills.
- Excellent communication skills, both written and verbal, with the ability to influence senior stakeholders.
- Ability to manage multiple priorities in a fast-paced, evolving environment.
- Travel availability up to 20% as required.
- Competitive base salary range of $104,934–$164,897, depending on experience and qualifications.
- Flexible work arrangements with remote-friendly and collaborative working environment.
- Comprehensive exposure to cutting-edge SaMD and regulated digital health development.
- Opportunities for professional growth, leadership development, and certification support.
- Engaging, agile-driven culture focused on innovation and continuous improvement.
- Travel opportunities for collaboration, audits, and company engagements.
- Strong emphasis on work-life balance with flexible scheduling.
Requirements:
Benefits:
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Date Posted
06/01/2026
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