Regulatory Affairs Specialist I- Remote

9 hours ago

Australia Angiodynamics, Inc. Full time

Posted Thursday, August 28, 2025 at 4:00 AM
Join a Team Committed to Improving Patient Care
AngioDynamics is dedicated to improving patient outcomes by developing innovative medical devices that address unmet needs. We support healthcare providers worldwide in delivering high-quality care through:
High standards of quality
Relentless innovation
Operational excellence
We offer comprehensive benefits supporting the health and wellness of our employees and their families.
Position Overview
The Regulatory Affairs Specialist is responsible for guiding the path to market for new and existing products, ensuring compliance with regulations in the intended markets, and supporting regulatory submissions and documentation.
Essential Duties and Responsibilities
Develop and maintain positive relationships with regulatory reviewers, managing pre-submission strategies and communications
Assist in developing regulatory strategies for new and modified devices
Research and recommend pathways for device approval (e.g., 510(k), PMA, Design Dossier)
Prepare and compile regulatory submissions and technical documentation for international markets
Review labeling and advertising for compliance
Manage product and manufacturing change documentation in accordance with regulations
Collaborate with cross-functional teams throughout product development
Coordinate with global regulatory agencies and partners
Qualifications
Bachelor's degree in a scientific or technical field, or equivalent experience
At least 1 year of regulatory affairs experience, preferably in the medical device industry
Knowledge of FDA and international regulations
Proficiency in Microsoft Office and understanding of product development processes
Strong communication, organizational, and analytical skills
Physical and Work Environment
This role may require travel up to 5% and involves typical office and laboratory work, including lifting up to 15 lbs frequently and up to 50 lbs occasionally.
Equal Opportunity Employment
We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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