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Regulatory Manager

Miramar, FL | Other
20 Days Ago

Job Description

NAGL MedTech provides comprehensive services in the medical device industry from product concept to commercialization.


When you join NAGL MedTech, you’re not joining another run of the mill corporate job where nothing you do truly matters. At NAGL MedTech, you are on the front lines of medical technology, creating devices that will shape the outcomes of millions of lives around the globe.



Our sole focus here at NAGL MedTech is to bring leading-edge medical technology ideas to life, through the work of our passionate associates. From neuro-catheter systems, robotic surgery devices and more, NAGL MedTech gives its associates the ability to truly shape the future through the research, design, and commercialization of industry changing technology.



We are industry changers. A group of people that come together every day to work towards a better tomorrow for everyone. We are a company not only focused on the growth of our success, but the growth of each associate; both professionally and personally.


GENERAL

The Regulatory Manager will lead the Regulatory group functions within the organization.


ESSENTIAL FUNCTIONS

  • Responsible for creative global regulatory and clinical strategies.
  • Conducts Initial OUS clinical studies.
  • Interfaces and negotiates with the FDA and international regulatory agencies.
  • Completes 510(k), IDE, PMA, and HDE applications.
  • Completes Technical Files and Design Dossiers.
  • Conducts product labeling and advertisement programs reviews.
  • Ensures Quality Systems are compliant with the FDA QSR and ISO 13485.
  • Oversees complaints and MDR/Vigilance Systems.
  • Oversees recalls and field actions.
  • In charge of Quality System auditing and training programs.


DESIRED KNOWLEDGE, SKILLS AND ABILITIES

  • A bachelor’s degree and 7 years of related experience OR an equivalent combination of education and experience is required.
  • Must be a specialist on complex technical and business matters.