Senior Compliance Specialist

ActiGraph is an international leader in the development of validated medical-grade wearable solutions used to measure physical activity, sleep, and behavior patterns in the broader global academic and pharma research communities. ActiGraph is looking for a Senior Compliance Specialist--this role is a critical contributor to the success of ActiGraph’s Quality Management System (QMS) and regulatory compliance efforts. This role combines traditional compliance responsibilities with elements of quality system analysis, risk management, and process improvement. The ideal candidate will bring a strong foundation in GCP and international medical device regulations, along with excellent technical writing and communication skills. This individual will support the implementation, maintenance, and continuous improvement of the QMS in accordance with ISO 13485, FDA 21 CFR 820, ICH GCP E6 R3, and global regulatory requirements, including manage complaint handling (including MDR reporting), CAPA support, audit support, and regulatory guidance while driving continuous quality improvement across the organization.   We are looking for an individual who possesses the ability to think outside the box, who has outstanding character while working within a team environment, possesses excellent communication skills, is a self-starter, has compassion for co-workers and clients alike, and has the ability to maintain a professional attitude and appearance under any circumstance, and able to teach/coach/mentor new team members. We hope you'll consider joining us in our mission to help bring digital data to life! Requirements Regulatory & Compliance Oversight  Maintain up-to-date knowledge of ICH GCP E6 R3, FDA, ISO 13485, EU MDR, and other relevant international regulations; communicate regulatory changes and implications to leadership and relevant stakeholders.  Provide regulatory guidance during product development, quality events, and operational changes.  Develop and maintain regulatory-related SOPs and ensure alignment with evolving requirements.  Quality System Management  Manage and support core QMS processes, including document control, complaint handling, Medical Device Reporting, CAPA, audit readiness, training, process validation, and Post Market Surveillance.  Serve as a key contributor to internal and external audits; assist with GxP audit preparation, hosting, response coordination, and CAPA follow-up.  Analyze quality data and KPIs to identify trends, risks, and opportunities for improvement.  Complaint Handling & CAPA  Oversee complaint investigation process, including root cause analysis and MDR evaluation.  Lead or support CAPA activities, including effectiveness checks and reporting of resolution status.  Collaborate cross-functionally to implement improvements and preventive actions based on findings.  Documentation & Technical Writing  Maintain controlled documents and records in the QMS.  Draft and review high-quality, accurate technical documents including SOPs, work instructions, validation reports, audit reports, and risk assessments.  Ensure documentation is audit-ready, compliant, and accessible.  Training & Communication  Manage training documentation and matrix maintenance.  Manage training setup and guidance on regulatory and quality system processes across departments.  Foster a culture of continuous improvement and compliance through proactive communication and collaboration.  Detailed Work Activities Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources.  Manage control system activities in the organization.  Review documents or materials for compliance with policies or regulations.  Develop operating strategies, plans, or procedures.  Implement organizational processes or policy changes.  Analyze data to identify trends or relationships among variables.  Collaborate with others to track, assess and resolve quality issues.  Assess risks to product and processes.  Using relevant information and individual judgment to determine whether events or processes comply with quality procedures, protocols, or standards.  Develop training strategies, plans, and procedures.  Required Qualifications Bachelor’s degree in a life science, engineering, or related field, or equivalent combination of education and experience.  Minimum 3 years of experience in a quality assurance, regulatory, or compliance role in a medical device, digital health, or life sciences environment.  Strong knowledge of Good Clinical Practice (GCP) and international regulatory requirements (e.g., FDA, ISO 13485, EU MDR).  Demonstrated experience with managing CAPAs and internal/external GCP audits is a must  Excellent technical writing and verbal communication skills; ability to synthesize complex information clearly and accurately.  Experience supporting cross-functional teams in a matrixed environment.  Analytical mindset with strong organizational skills and attention to detail.  Proficient in Microsoft365.  Preferred Qualifications Experience with QMS tools (specifically QT9) preferred.  Experience in a fast-paced, innovative, or scaling organization preferred.  Familiarity with digital health technologies or wearable medical devices preferred.  Experience with complaint handling and Medical Device Reporting.  Benefits At ActiGraph, we do our best to offer benefits and a work environment that is positive, fun, and tailored towards the needs and feedback of our team members. We do so by offering: A casual "dress-code" environment A family-oriented and collaborative workplace Paid time off (including paid time off for your birthday) And a very generous suite of benefits including: medical, dental, vision, basic/life accidental, short/long term disability, identity theft, 401K (plus a match), and supplemental insurance options