Factory Regulatory Affairs Manager

Hospitalet de Llobregat, L

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Description

We are Impress. We believe everyone deserves a smile they’ll love.


We are the largest chain of ortho clinics with fully digital processes in Europe. We have revolutionised the invisible orthodontic sector with the best team of professionals specialised in making people smile and using the latest technology for the diagnosis, treatment, and follow-up of all cases.


Our business model, a true combination of medical expertise and digitalisation has been recognised in the top fastest-growing HealthTech companies by Forbes.


Born in Barcelona in 2019, in just 3 years, we’ve grown to pioneer leading care, flagship clinics, and state-of-the-art tech across 8 countries and more than 130 locations and we are expanding fast! We improve people’s health and quality of life across the globe.


As our factory team is growing, we are seeking a Regulatory Affairs Manager to join our team and help ensure that our products comply with all relevant regulations and standards.


Job Overview:


The Regulatory Affairs Manager will be responsible for developing and implementing regulatory strategies for our product: invisible orthodontics aligners. They will work closely with cross-functional teams, including R&D, Quality, Operations, and Marketing, to ensure that our products meet all regulatory requirements and are launched successfully in various markets.


Key Responsibilities:


  • Develop and implement regulatory strategies for invisible orthodontics aligners in various markets.
  • Ensure compliance with all relevant regulations and standards, including FDA, CE, and other country-specific regulatory bodies.
  • Collaborate with cross-functional teams to ensure regulatory requirements are incorporated into product development plans and timelines.
  • Review and approve labeling, advertising, and promotional materials for compliance with regulatory requirements.
  • Prepare and submit regulatory filings, including 510(k) submissions, CE mark applications, and other country-specific regulatory submissions.
  • Maintain regulatory documentation and ensure compliance with internal quality systems and procedures.
  • Monitor and analyze regulatory developments and assess their impact on our products and business.
  • Build and maintain relationships with regulatory agencies and industry associations to stay informed on regulatory trends and changes.

Requirements

  • Bachelor's degree in a scientific discipline, such as biology, chemistry, or engineering. Advanced degree preferred.
  • Minimum of 10 years of experience in regulatory affairs in the medical device industry, with a focus on orthodontic products preferred.
  • In-depth knowledge of FDA regulations, CE requirements, and other country-specific regulatory requirements.
  • Strong communication, collaboration, and project management skills. Fluent English is a must, other languages are welcome too.
  • Ability to work effectively in a cross-functional, multi-cultural team environment.
  • Strong attention to detail and ability to manage multiple projects simultaneously.
  • Strong analytical and problem-solving skills.
  • Ability to adapt to changing regulatory requirements and industry trends.
  • Experience with 510(k) submissions and CE mark applications.
  • Experience with electronic document management systems (EDMS) preferred.

Location