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Regulatory Specialist III

1 month ago

Fort Worth, United States Astrix Full time

Exciting development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.


Regulatory Specialist III/Associate Director of Regulatory Compliance

  • Lead and oversee the strategic and operational aspects of regulatory labeling for medical devices.
  • Ensuring that all labeling activities comply with international regulations and standards, while effectively managing labeling content and artwork approvals.
  • Advancing regulatory labeling practices, enhancing labeling processes, and integrating technology to streamline future operations.
  • Deep understanding of global medical device regulations, including FDA 21 CFR Part 801, European MDR/IVDR, and other relevant standards.
  • Familiarity with ISO standards related to labeling, such as ISO 15223-1 and ISO 13485, and knowledge of labeling requirements across major markets, including the US, EU, and Canada – additional regions a plus.
  • Develop and implement labeling strategies to ensure compliance with global medical device regulations and standards, including FDA, CE Marking, and ISO.
  • Support regulatory objectives such as Post Production Risk Reviews (PPRR), Clinical Evaluation Report (CER), labeling gap assessments, and labeling technical documentation.
  • Lead efforts to integrate advanced technologies and automation solutions to enhance labeling processes and operational efficiency.
  • Drive continuous improvement initiatives to optimize labeling processes, increase efficiency, and ensure regulatory compliance.


Education:

  • Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related field. Advanced degree (Master’s or Ph.D.) is preferred.
  • Minimum of 7-10 years of experience in regulatory affairs or labeling for medical devices, with significant experience in managing labeling content and artwork approvals.


This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you