Quality Assurance/ Regulatory Affairs Associate
Il y a 3 mois
We are thrilled to be one of Deloitte's 500 fastest growing technology companies in the US - and now, we are ready to take our success to the next level by going public This is an incredible opportunity to join our team as a Quality Assurance/ Regulatory Affairs AssociateSpecialist and help us reach new heights.
At Allurion, our core values of Audacity, Grit, Authenticity, Accountability, and being Data Driven, combined with our passion for innovation, have fueled our growth and will help us achieve our ambitious mission - ending obesity As part of a recognized Great Place to Work ® in the US, UK, France, Allurions engage as a collaborative global team while solutioning a critical healthcare challenge which affects millions. We are driven by purpose, motivated by individual challenge and growth, and energized by collective engagement and competitive rewards. We invite you to join us as we aim to transform the way obesity is treated and make a lasting impact on the world.
**What will you be doing?**
The Quality Assurance/ Regulatory Affairs Associate (Paris) Oversees and directs QA regulatory activities for new and mature international territories to ensure alignment and compliance with local and regional registration requirements.
- Works under Director International QA/RA supervision following Allurion established procedures.
- Review and update the International RA planning, Roadmap & keep all database & project trackers updated
- Submissions preparation for new product introductions, license renewals and product changes in various regions
- Review product labeling and marketing materials to ensure compliance with regulatory requirements
- Maintain knowledge on changing worldwide regulations and standards that are pertinent to Allurion’s business (Latin America and middle east countries)
- Obtains Certificates (CFG, FSC) to support international registrations & Coordinate legalization
**What we’re looking for in you**:
- Pharmacist experience a plus
- Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders
- Ability to think strategically, and to interpret and act upon complex or ambiguous issues, in both the immediate and broader context
- Demonstrates in-depth understanding of advanced technical/scientific principles that relate to a specific product line
- Previous experience in regulatory affairs (minimum 2 years) in the region in a Cosmetic/chemical company or in Quality management or in any related field
- Global regulatory affairs and compliance experience is required
**What’s in it for you**:
- Competitive Package
- Paid Time Off
- Training and Career Development
- Global Employee Assistance Program & Total Wellbeing Platform
- Employee Stock Purchase Program
- Benefits and perks are tailored to your country of residence
**Location**:
This exciting role is based in our office in Paris, France and will require hybrid work in office
**Travel**:
There is potential for some international travel for company sponsored events.
**Hours**:
- Diversity and Inclusion_
To learn more about Allurion please visit our website
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