Director of Regulatory Affairs

Paris  - CDI

À propos de DENTAL MONITORING

About


DENTAL MONITORING (www.dental-monitoring.com) is the world’s first SaaS application designed for remote monitoring of dental treatment. The Dental Monitoring Artificial Intelligence software is able to detect more than 170 clinical situations from intra-oral photos taken by the patient with the DM mobile App.

DM provides a customizable platform to automatically deliver messages to patients and instructions to the practice team, based on protocols designed by the dental Professional and clinical events detected by the AI.

Dental Monitoring just closed a 45M€ funding backed by UK based VC Vitruvian Partners, that will enable the company to accelerate its international development.

Dental Monitoring is seeking a Director of Regulatory Affairs, located in Paris, France. This role entails leading the Customer Success teams across the world, implementing scalable and efficient processes and strategies, and ensuring the success and growth of an assigned portfolio of strategic customers.



Description du poste

WHAT YOU'LL DO

  • Lead in the development, preparation, management, and submission of regulatory applications and related supplements and amendments for innovative products;
  • Design regulatory strategies for assigned programs and work with internal product and quality teams on execution;
  • Work on cross-functional teams and projects and provide regulatory guidance and education through the interpretation of laws, regulations, policies, procedures, guidelines, and compliance requirements;
  • Interact directly with regulatory health authorities;
  • Develop and maintain a Quality Management System;
  • Train on regulatory requirements and collect and disseminate intelligence on evolving laws, requirements, policies, and trends as relevant to the business;
  • Ensure compliance to data and healthcare laws relevant to medical devices (e.g., MDR, HIPAA, GDPR...);

Description du profil

WHAT YOU'LL NEED

  • 5-10 years of regulatory affairs experience;
  • Experience directing or managing a regulatory affairs team;
  • Experience in executing regulatory strategy for assigned programs;
  • Exceptional writing skills with experience in drafting and submitting regulatory submissions to regulatory authorities (for FDA, PMA experience preferred);
  • Cross-functional problem solving skills;
  • Exceptional communication and presentation skills;
  • Ability to communicate regulatory requirements to cross-functional teams;
  • Experience in creating and maintaining a corporate culture of compliance;
  • Quality System Regulation (and ISO 13485) knowledge preferred;
  • Someone who's fun, ambitious but humble;

BONUS POINTS IF

  • Experience in regulatory affairs for Medical Devices;
  • Experience in a fast-growing environment;
  • Fluent in French;

WHAT YOU'LL EXPERIENCE

  • Amazing offices in the center of Paris;
  • Evolving in a hyper growth environment;
  • Daily chat with collaborators coming +27 different countries;

WORK @ Dental Monitoring

  • We are Fam: what's the point spending all these hours together if we don't have fun?
  • Loyalty matters: we care about DM. We are building something meaningful together;
  • Go fast and Break things: we work quickly;
  • humbleness: no ego;
  • Honesty: No bullshit;
  • Think BIG: each one of us has to always shoot for bigger, faster, better. Always...

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