Ametris (formerly ActiGraph)
Senior Compliance Specialist
Ametris (formerly ActiGraph), Pensacola, Florida, United States, 32573
Overview
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 global academic and pharma research communities. ActiGraph is seeking a Senior Compliance Specialist to contribute to the Quality Management System (QMS) and regulatory compliance efforts. This role combines regulatory responsibilities with quality system analysis, risk management, and process improvement. The ideal candidate will have a strong foundation in GCP and international medical device regulations, with excellent technical writing and communication skills. The individual will support the implementation, maintenance, and continuous improvement of the QMS in compliance 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. Responsibilities 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. 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. 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. 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. Manage training documentation and matrix maintenance; guide regulatory and quality system processes across departments. Foster a culture of continuous improvement and compliance through proactive communication and collaboration.
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. 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 Microsoft 365.
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
ActiGraph offers a positive, collaborative work environment with a range of benefits, including: A casual dress-code environment A family-oriented and collaborative workplace Paid time off (including paid time off for your birthday) Medical, dental, vision, basic/life accidental, short/long term disability, identity theft, 401K (with match), and supplemental insurance options
General
Seniority level: Associate Employment type: Full-time Job function: Quality Assurance Industries: IT Services and IT Consulting
Referrals increase your chances of interviewing at Ametris (formerly ActiGraph) by 2x. Get notified about new Senior Compliance Specialist jobs in Pensacola, FL. Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
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 global academic and pharma research communities. ActiGraph is seeking a Senior Compliance Specialist to contribute to the Quality Management System (QMS) and regulatory compliance efforts. This role combines regulatory responsibilities with quality system analysis, risk management, and process improvement. The ideal candidate will have a strong foundation in GCP and international medical device regulations, with excellent technical writing and communication skills. The individual will support the implementation, maintenance, and continuous improvement of the QMS in compliance 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. Responsibilities 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. 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. 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. 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. Manage training documentation and matrix maintenance; guide regulatory and quality system processes across departments. Foster a culture of continuous improvement and compliance through proactive communication and collaboration.
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. 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 Microsoft 365.
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
ActiGraph offers a positive, collaborative work environment with a range of benefits, including: A casual dress-code environment A family-oriented and collaborative workplace Paid time off (including paid time off for your birthday) Medical, dental, vision, basic/life accidental, short/long term disability, identity theft, 401K (with match), and supplemental insurance options
General
Seniority level: Associate Employment type: Full-time Job function: Quality Assurance Industries: IT Services and IT Consulting
Referrals increase your chances of interviewing at Ametris (formerly ActiGraph) by 2x. Get notified about new Senior Compliance Specialist jobs in Pensacola, FL. Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr