Job Title: Senior Regulatory Specialist Job Location: Gainesville, FL, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Associate Department: Regulatory Location: US (Remote)

Description

The purpose of the Senior Regulatory Specialist is to provide services to fulfill the regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company.

Key Responsibilities

With minimal oversight, preparing and maintaining pre-market submissions or post-market change submissions for a variety of markets. With minimal oversight, provide project-level regulatory strategy and support for new product development projects, post-market lifecycle projects, Quality System updates, business development projects: Project team RA lead member Assess and approve post-market changes Assess and approve product and process Nonconformances and deviations Own and execute CAPA for Regulatory processes

Skills Knowledge and Expertise

Education: Bachelor’s Degree from an accredited institution required. Experience: Minimum 5 years experience in FDA/ISO medical devices quality management system standards required 5 years experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations required Functional/Technical Knowledge, Skills and Abilities Required: Technical writing skills required

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