Factory Regulatory Affairs Manager

hace 1 día

l'Hospitalet de Llobregat, España Impress A tiempo completo

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.
- 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 electronic document management systems (EDMS) preferred.

10 years

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