Senior Compliance Specialist
Apply NowLocation:
Pensacola, FL, US
Company:
ActiGraph is an international leader in the development of validated medical-grade wearable solutions for measuring physical activity, sleep, and behavior patterns.
Summary:
The Senior Compliance Specialist will contribute to ActiGraph's Quality Management System and regulatory compliance efforts while supporting continuous quality improvement initiatives. Candidates should have a relevant degree, experience in compliance, and strong knowledge of GCP and medical device regulations.
Requirements:
Technology: Proficient in Microsoft365
Hard Skills: Strong knowledge of Good Clinical Practice (GCP) and international regulatory requirements (e.g., FDA, ISO 13485, EU MDR), Excellent technical writing and verbal communication skills; ability to synthesize complex information clearly and accurately, Analytical mindset with strong organizational skills and attention to detail
Credentials: Bachelor’s degree in a life science, engineering, or related field
Experience: Minimum 3 years of experience in a quality assurance, regulatory, or compliance role in a medical device, digital health, or life sciences environment, Demonstrated experience with managing CAPAs and internal/external GCP audits
Job Description:
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!
