Senior Compliance Specialist

Job Description

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!

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

Complaint Handling & CAPA

Documentation & Technical Writing

Training & Communication

Detailed Work Activities

Required Qualifications

Preferred Qualifications

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 :