Regulatory Affairs Associate

Company: Remington Medical Inc
Location: Alpharetta
Posted on: September 3, 2024

Job Description:

Description:Position InformationPosition Title:Regulatory Affairs Associate I and IIDepartment Name:Quality/RegulatoryPay Status:SalaryDepartment No.:24Department Head:VP of Quality and Regulatory Affairs
Section 1 - Job Functions and ResponsibilitiesEssential Duties and Responsibilities

• 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).
• Support continual regulatory activities to maintain compliance (i.e. CERs, PMS', PSURs, etc.)
• Perform gap analysis as needed when standards are revised to maintain compliance.
• Conduct research to develop additional regulatory knowledge of worldwide guidelines, standards, and regulations based on business needs.
• 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.
• As needed, provide regulatory consulting assistance for Contract Manufacturing customers.
• Compile US FDA, EU, and other regional UDI information for submission to the appropriate UDI databases.
• Maintain Company status within FURLS, Eudamed, and other international medical products databases.
• 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.
• 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.
• Review/approve Design History File and Technical File documents for compliance with requirements of applicable regulations, standards, and the QMS.
• Assist with the renewal of applicable registrations and licenses.
• Support QMS and RA projects to achieve compliance with new or revised regulatory requirements.
• Assist in preparation and execution of vigilance activities.
• Assist in preparation for and conduction of internal and external audits.
• Maintain regulatory affairs files (e.g. scan, print, file) per Quality System and regulatory requirements.
• 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.
  Essential Physical Demands of the PositionThe following demands are essential for adequate performance in this position. Remington Medical will make reasonable accommodations for persons affected under the Americans with Disabilities Act.Standing Time:15 - 40%Keyboard Time:41 - 70% Lifting:5 - 25 lbs.
  Essential Sensory Demands of the PositionThe following demands are essential for adequate performance in this position. Remington Medical will make reasonable accommodations for persons affected under the Americans with Disabilities Act.Audible Sensory:Normal ConversationVisual Concentration:15 - 40%Color Perception:Not Essential
  Working ConditionsWork HoursWork may require extended work hours during peak periods.TravelWork may require light overnight business travel (less than 1 trip per quarter).
  Other DutiesJob duties other than those specifically detailed in this job specification may be assigned from time to time if deemed necessary for the orderly conduct of business. Such assignments may become a permanent element of this position. Management at any time as deemed necessary may make changes to this job description. This document does not serve as a checklist for promotion criteria.Requirements:Section 2 - Minimum Position Qualifications
  Qualified Candidate Requirements Summary
• Bachelors degree in engineering or life sciences required (or related degree).
• Experience in interpreting US and international regulatory requirements and successful submissions for medical devices (510k's, CE mark technical files, etc.) strongly desired.
• 1+ years of related experience in medical device or FDA-regulated industry
• RAC certification preferred or other relevant certifications.
• High level of competency in FDA QSRs, ISO 13485, and other regulatory requirements.
• 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.Relevant Work Experience (in a related field)Required Length of Service: 1-2 yearsDesired Length of Service:3-5 yearsOther Experience Requirements: Life Science Industries
  Minimum Education LevelEducation Level Required:Bachelor's Degree (or equivalent degree)Education Level Preferred:Master's Degree (or equivalent degree)Equivalent Work ExperienceOther Education Requirements: Engineering or Science DegreeOther Education Preferences:Other Technical Degree: Master of Science in Engineering, Science, or Regulatory Affairs preferred
  Other Desired Training, Skills, and Certifications
• RAC certification preferred Remington Medical is an Equal Opportunity Employer.
  
  
  
  
  PIbddf84f2e387-37248-35429642

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