Senior Compliance Specialist - Remote

Overview

ActiGraph is looking for a Senior Compliance Specialist who will be a critical contributor to the success of ActiGraph’s Quality Management System (QMS) and regulatory compliance efforts, combining traditional compliance responsibilities with quality system analysis, risk management, and process improvement.

In Short

• Act as a key contributor to the Quality Management System.
• Support regulatory compliance efforts in accordance with international standards.
• Manage complaint handling and MDR reporting.
• Provide CAPA support and audit assistance.
• Drive continuous quality improvement across the organization.
• Possess strong foundation in GCP and medical device regulations.
• Demonstrate excellent technical writing and communication skills.
• Work collaboratively within a team environment.
• Mentor and coach new team members.
• Maintain professionalism under various circumstances.

Requirements

• Strong understanding of GCP and international regulations.
• Experience in quality management systems and regulatory compliance.
• Excellent communication and technical writing skills.
• Ability to think outside the box.
• Compassion for co-workers and clients.
• Self-starter with a professional attitude.
• Experience in risk management and process improvement.
• Ability to mentor and coach others.
• Strong character and teamwork skills.
• Willingness to support continuous improvement initiatives.

Benefits

• Opportunity to work in a leading company in the wearable technology space.
• Engage in meaningful work that impacts global health.
• Collaborative and supportive team environment.
• Professional development opportunities.
• Work with innovative technology and solutions.
• Contribute to continuous improvement initiatives.
• Flexibility in work arrangements.
• Competitive compensation package.
• Access to industry-leading training and resources.
• Be part of a mission-driven organization.