Manager of Compliance [Remote]

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.

Requirements:

• 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.

Benefits:

• 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.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.