Regulatory Affairs Associate USA

Vienna - Austria

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

Join the MADx Revolution.

We have revolutionized allergy diagnostics and have been operating successfully in more than 90 countries for over 9 years with our diagnostic products and patented technologies. Our products help clarify allergies in a single step for humans and animals alike. Allergies are diagnosed with high specificity enabling patients to receive help from their specialists in no time. We improve quality of life enable personalized treatment advance research and relieve the burden on our healthcare system.

Key Responsibilities:

Preparing maintaining reviewing and updating regulatory and technical documentation to support FDA submissions including Pre-Submissions (Q-Subs) and preparation coordination and participation in FDA meetings
Acting as a primary regulatory interface for communication with the FDA including drafting coordinating and submitting responses to FDA inquiries within defined timelines
Preparing and supporting activities required for FDA clearance approval and ongoing compliance including 510(k) DeNovo and PMA submissions as applicable
Supporting the development implementation and continuous optimization of the regulatory strategy for the US/FDA market
Working closely with the Regulatory Affairs team in Vienna to ensure alignment between US and global regulatory activities
Coordinating regulatory activities with our US-based regulatory consultant and internal cross-functional stakeholders
Ensuring a thorough understanding and correct interpretation of FDA regulations applicable to in vitro diagnostic medical devices with a strong focus on multiplex tests
Supporting internal and external audits FDA inspections and regulatory reviews including preparation of documentation follow-up actions and responses
Contributing to post-market surveillance change management and life-cycle activities as well as the preparation and maintenance of SOPs work instructions and templates where relevant

Your Profile:

Degree in medical technology biology biochemistry or a comparable scientific discipline
4 - 7 years of experience in Regulatory Affairs for medical devices and/or in-vitro diagnostics
Solid experience with FDA regulations and submission pathways (e.g. Pre-Sub (Q-Sub) 510(k) De Novo PMA depending on product classification and regulatory strategy)
Strong understanding of FDA requirements for multiplex and molecular diagnostic tests including analytical and clinical performance expectations
Experience working with international regulatory teams and external consultants is highly desirable
Structured detail-oriented working style with the ability to work independently as well as collaboratively in a cross-functional environment
Strong written and verbal communication skills with a proactive solution-oriented mindset
Excellent command of English (written and spoken)

Join the MADx Revolution.We have revolutionized allergy diagnostics and have been operating successfully in more than 90 countries for over 9 years with our diagnostic products and patented technologies. Our products help clarify allergies in a single step for humans and animals alike. Allergies ar...

Join the MADx Revolution.

Key Responsibilities:

Preparing maintaining reviewing and updating regulatory and technical documentation to support FDA submissions including Pre-Submissions (Q-Subs) and preparation coordination and participation in FDA meetings
Acting as a primary regulatory interface for communication with the FDA including drafting coordinating and submitting responses to FDA inquiries within defined timelines
Preparing and supporting activities required for FDA clearance approval and ongoing compliance including 510(k) DeNovo and PMA submissions as applicable
Supporting the development implementation and continuous optimization of the regulatory strategy for the US/FDA market
Working closely with the Regulatory Affairs team in Vienna to ensure alignment between US and global regulatory activities
Coordinating regulatory activities with our US-based regulatory consultant and internal cross-functional stakeholders
Ensuring a thorough understanding and correct interpretation of FDA regulations applicable to in vitro diagnostic medical devices with a strong focus on multiplex tests
Supporting internal and external audits FDA inspections and regulatory reviews including preparation of documentation follow-up actions and responses
Contributing to post-market surveillance change management and life-cycle activities as well as the preparation and maintenance of SOPs work instructions and templates where relevant

Your Profile:

Degree in medical technology biology biochemistry or a comparable scientific discipline
4 - 7 years of experience in Regulatory Affairs for medical devices and/or in-vitro diagnostics
Solid experience with FDA regulations and submission pathways (e.g. Pre-Sub (Q-Sub) 510(k) De Novo PMA depending on product classification and regulatory strategy)
Strong understanding of FDA requirements for multiplex and molecular diagnostic tests including analytical and clinical performance expectations
Experience working with international regulatory teams and external consultants is highly desirable
Structured detail-oriented working style with the ability to work independently as well as collaboratively in a cross-functional environment
Strong written and verbal communication skills with a proactive solution-oriented mindset
Excellent command of English (written and spoken)