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