Regulatory Affairs Manager

4 weeks ago


Des Plaines, United States Aesku Inc Full time

Introduction to AESKU:

Headquartered in Wendelsheim, Germany, AESKU was founded by Dr. Torsten Matthias in 2000 to make autoimmunity testing simpler, more efficient, and more accurate for patients and laboratories around the world. We have since expanded to manufacture equipment and software in-house, along with allergy and infectious disease diagnostics for distribution in over 80 countries. Along with our focus on in-house research and development, one thing that sets us apart from other companies is our collaborative, results-oriented culture.



Benefits of joining us:

·        You would join our diverse global team and work with colleagues in global registrations, operations, and quality management to operate clinical trials and registrations for North and South America.

·        You would have total ownership of registrations for your regions and significant autonomy not found in larger companies, while having support and resources not found in smaller, less established companies.


We offer medical, dental, vision, short term disability, long term disability, FSA and 401K


Responsibilities

Job Description:

Core responsibility is to execute the regulatory registrations strategy for new submissions and post market changes (mostly FDA 510k or simple country listings) in the US for North and South America. Including responsibilities for the following:

·        Design studies with input from marketing and R&D, and (as needed) regulatory consultants, minimizing samples and tests required.

·        Coordinate with sample vendors and internal trial sites to procure, store, and manage trial samples in AESKU biobank.

·        Coordinate trial testing with internal trial sites.

·        Prepare and successfully submit regulatory documentation to regulatory agencies.

·        Compile materials for license renewals, updates, and registrations.

·        Maintain regulatory files/database and chronologies in accordance with AESKU Quality Management System.

·        Comply with AESKU QMS system for tracking changes in documents submitted to agencies or partners.

·        Review labeling and label design for compliance with regulatory requirements. 

·        Review changes to existing products and SOPs to define the requirements for regulatory submissions.

·        Provide regulatory reviews of customer complaints and define the regulatory reportability.

·        Maintain current knowledge of FDA and international domain regulation, guidance, and standards applicable to company products. Notifying QA and senior management as needed.

·        Advise on regulatory compliance of document / product / process / test methods changes.


Qualifications

Preferred Qualifications:

·        8+ years relevant experience within the regulatory affairs discipline

·        Experience with Ex-US registrations, especially for Latin American countries.


Required Qualifications:

·        A BA degree, or higher, in a science or related field

·        At least 5 years relevant experience within the regulatory affairs discipline

·        Knowledge of US and international medical device regulatory requirements

·        Experience with a Quality Management System (QMS) like Greenlight Guru

·        Experience with a 510(k) or PMA submission

·        Fluent in English, both reading and writing



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