CONFLUX SYSTEMS ยท 2 hours ago
Regulatory Affairs Associate
San Diego, CA
Contract
Hybrid
Entry, Mid Level
$35/hr - $35/hr
2+ years expCONFLUX SYSTEMS is seeking a Regulatory Affairs Associate to provide regulatory support and expertise for US and global submission requirements. The role involves maintaining regulatory compliance, preparing registration packages, and collaborating with regulatory agencies to ensure product approvals.
ConsultingInformation Technology
Hiring Manager
Rebecca Beck
Responsibilities
Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations
Plans and organizes registration packages for device products. Prepares registration packages in line with regional regulatory requirements and guidelines
With oversight, understand and respond to regulatory agencies or notified body correspondences
Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review
Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission
Identify registration documentation deficiencies and work with colleagues to accomplish resolution
Understand global regulations and assure regulatory compliance, minimizing development costs and cycles
Exercise good judgment within policy and regulations
Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters
Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team
Reviews regulatory commitments, strategy decisions, meeting strategies with regulatory authorities and changes to resource allocations with manager prior to execution
Work on special projects as assigned
Qualification
Required
Proven strong understanding of FDA, EU and worldwide submission requirements
Proven strong record of preparing regulatory submissions and obtaining approvals
Identify registration documentation deficiencies and work with colleagues to accomplish resolution
Understand global regulations and assure regulatory compliance, minimizing development costs and cycles
Prepare and maintain regulatory strategy with supervision
Advanced experience with assembling global dossiers
Two to four years of medical device industry experience with regulatory affairs with direct FDA and global submission experience and authoring CE technical documentation
Strong understanding of 21 CFR 820 and ISO 13485:2016 requirements
Well-developed experience working directly with regulatory agencies. Sound knowledge of applicable portions of agency regulations and applicable guidance documents
Advanced ability to critically assess scientific arguments
Excellent oral and written communication skills
Strong problem-solving skills
Excellent interpersonal skills
Well-developed negotiating skills. Strong understanding of business needs
Bachelor's Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject
A minimum of two years of experience in Medical Products Industry in Regulatory Affairs
Able to assess scientific arguments and apply analytical and logical reasonings
Ability to effectively prioritize workload and multitask with minimal supervision
Good interpersonal skills
Good oral and written communications skills
Demonstrated project management skills
Demonstrated critical thinking, contingency planning and negotiating skills
Understanding regulatory and business needs with ability to engage cross functional team members
Demonstrated critical thinking, contingency planning and negotiating skills
Understanding of regulatory and business needs with ability to establish direction and influence cross functional team members
Preferred
RAC Certification preferred
Company
CONFLUX SYSTEMS
Conflux Systems, Inc. is a business consulting firm specializing in software development and business intelligence.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase