Regulatory Affairs Associate

Company: Remington Medical Inc
Location: Alpharetta
Posted on: March 19, 2023

Job Description:

Description: 1. Regulatory Affairs Associate I and II positions are essentially the same. However, a Regulatory Affairs Associate II would be expected to achieve a higher level of output and a higher level of quality of work than a Regulatory Affairs Associate I.2. Support the delivery of timely regulatory applications for national (e.g., FDA 510(k)'s, IDE's, PMA's) and international marketing approvals (i.e. CE Mark technical files and Canadian licenses).3. Conduct research to develop additional regulatory knowledge of worldwide guidelines, standards, and regulations based on business needs. 4. Support Engineering and R&D project teams by providing guidance for interpretation of regulatory requirements, guidance documents, and other applicable standards for RMI and RMSA.5. As needed, provide regulatory consulting assistance for Contract Manufacturing customers.6. Compile US FDA, EU, and other regional UDI information for submission to the appropriate UDI databases.7. Maintain RMI and RMSA's status within FURLS, Eudamed, and other international medical products databases.8. Interface with Customer Service, Sales, Engineering, and R&D to answer inquiries regarding product claims, regulatory submission numbers, design validation and verification data, material/hazardous substance declarations, etc.9. Review Document Change Orders (DCOs) and Engineering Change Orders (ECOs) for Regulatory compliance, including reviews of design and manufacturing process changes for significant changes which require regulatory body notifications.10. Review/approve Design History File and Technical File documents for compliance with requirements of applicable regulations, standards, and the QMS. 11. Support QMS and RA projects to achieve compliance with new or revised regulatory requirements.12. Assist in preparation and execution of vigilance activities.13. Assist in preparation for and conduction of internal and external audits.14. Maintain regulatory affairs files (e.g. scan, print, file) per Quality System and regulatory requirements.15. Adhere to Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO, FDA, and all applicable international requirements.Other tasks as needed per supervisor. Requirements: 1. Bachelors degree in engineering or life sciences required (or related degree). 2. Experience in interpreting US and international regulatory requirements and successful submissions for medical devices (510k's, CE mark technical files, etc.) strongly desired.3. 1+ years of related experience in medical device or FDA-regulated industry4. RAC certification preferred or other relevant certifications.5. High level of competency in FDA QSRs, ISO 13485, and other regulatory requirements.6. Demonstrated ability to communicate and work effectively as a team member and colleague within functional team processes.Excellent communication, prioritization, and organizational skills with experience communicating quality metrics and directives to senior management and company staff.




PI206311171

Keywords: Remington Medical Inc, Alpharetta , Regulatory Affairs Associate, Other , Alpharetta, Georgia