Address
Form of work
SalaryDescription:
This is a hybrid position.
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.
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
Preferred Qualifications:
- 8+ years relevant experience within the Regulatory Affairs discipline
- Experience with Ex-US registrations, especially for Latin American countries.
