Senior Regulatory Affairs Specialist

Company: ALPCO
Location: Salem
Posted on: January 22, 2023

Job Description:

The Senior Regulatory Affairs Specialist provides information, assistance and clarification to individuals concerning regulatory affairs. The Sr. Regulatory Affairs Specialist is a regulatory specialist that will be responsible for product submissions, periodic updates, and registrations to regulatory agencies. This individual will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings, and research regulatory issues and provide guidance and advice to colleagues.The Senior Regulatory Affairs Specialist reports to the VP of Quality & Regulatory.RESPONSIBILITIES

• Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy for US and International submissions
• Timely compilation of materials for license renewals, updates, and registrations
• Maintain regulatory files/database and chronologies in good order
• Review labeling and labels for compliance with regulatory requirements
• Review changes to existing products and SOPs to define the requirements for regulatory submissions
• Provide the regulatory reviews of customer complaints and define the regulatory reportability, vigilance and responses to regulatory agencies as needed
• Drive Post Market Surveillance activities
• Responsible for timely registration of the facility
• Maintain current knowledge of FDA and international regulation, guidance, and standards applicable to company products
• Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes
• Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required
• Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process
• Complete submissions to FDA, EU regulatory entities
• Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws
• Manage SOP's and work instructions relative to regulatory responsibilities
• Play a supporting and/or backup role on broader Quality Assurance and QMS related responsibilities.
• All other duties as assigned. SKILLS AND QUALIFICATIONS
  • Working knowledge of FDA regulations associated with operating a high-quality manufacturing environment.
  • Excellent organizational and interpersonal skills, including the ability to successfully work with internal and external customers
  • Solid track record at attaining FDA 510k clearances, DeNovo or PMA approvals preferably with reagent based IVD devices
  • Familiar with attaining the CE mark under IVDD and the upcoming IVDR requirements
  • Strong analytical skills and excellent communication and presentation skills (both written and verbal)
  • Ability to work effectively in a fast paced, deadline-oriented environment EDUCATION
    • Bachelor's Degree (Master's preferred) and 7-10 years in a GMP environment, In Vitro Diagnostic (IVD), Pharmaceutical, Life Science, Biotech, or Medical Device experience preferred Get news & resources delivered to your inbox
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Keywords: ALPCO, Salem , Senior Regulatory Affairs Specialist, Other , Salem, Oregon