Market Compliance Expert

1 day ago

Australia beBeeRegulation Full time $81,919 - $123,456
Regulatory Affairs Specialist

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.

Job Description

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.

  1. Develop and maintain positive relationships with regulatory reviewers, managing pre-submission strategies and communications
  2. Assist in developing regulatory strategies for new and modified devices
  3. Research and recommend pathways for device approval (e.g., 510(k), PMA, Design Dossier)
  4. Prepare and compile regulatory submissions and technical documentation for international markets
  5. Review labeling and advertising for compliance
  6. Manage product and manufacturing change documentation in accordance with regulations
  7. Collaborate with cross-functional teams throughout product development
  8. Coordinate with global regulatory agencies and partners
Required Skills and Qualifications

• Bachelor's degree in a scientific or technical field

• 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

Benefits

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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