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Katalyst HealthCares & Life Sciences
Regulatory Affairs SpecialistKatalyst HealthCares & Life Sciences • Seattle, WA
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Katalyst HealthCares & Life Sciences • Seattle, WA
30+ days ago
Job type
  • Full-time
Job description

Job Description:
We are looking for a Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist provides leadership and input on company strategies and programs involving regulatory and government agencies; helps to develop strategies to ensure regulatory requirements are met; determines requirements, then compiles and files applications for sale of Innovasis products with regulatory and government agencies; provides regulatory input to project teams; plans and implements policies, procedures, practices, and strategies for Regulatory Affairs. The position provides backup for interfacing with regulatory bodies and/or Auditing Organization(s).
Responsibilities:
  • Assists in developing the company's quality management system in compliance with all relevant standards and regulations.
  • Prepares appropriate technical, quality, manufacturing, and regulatory data and documentation for the purpose of supporting QMS certification and developing regulatory submissions to FDA and applicable foreign regulatory bodies.
  • Prepares and submits regulatory filings, such as FDA (k) and other domestic and foreign/Outside (OUS) regulatory filings, submissions, and trademarks.
  • Prepares and maintains documentation (, Technical Files) to support OUS product registrations and licensing.
  • Identifies key activities for regulatory goals for assigned project teams and sets clear targets to achieve results.
  • Maintains a professional and credible image with FDA, Auditing Organization(s), foreign partners/representatives and OUS regulatory agencies.
  • Keeps abreast of ongoing regulatory changes and new regulations. Aids in analyzing proposed new and/or changed regulations, their impact to the company's products and processes and assesses their implications to the company's current and future business activities.
  • Collaborates with R&D Engineering, Manufacturing, Marketing and Quality Functions as needed to execute regulatory strategy throughout Total Product Lifecycle (TPLC).
  • Aids in identifying quality issues and developing corrective and preventive action plans.
  • Monitors product labels and labeling to ensure compliance with relevant standards and regulations.
  • Develops and provides training to selected staff relative to the requirements of regulatory and/or QMS matters.
  • Reviews and approves MedWatch and Vigilance reports. Leads product advisory/recall activities and coordinates with regulatory authorities.
  • Provides regulatory review and approval of technical and QMS documentation.
Requirements:
  • Bachelor's degree in biology, Engineering, Degree in other fields may be considered depending on the degree field and experience/relevance within the medical device industry.
  • Regulatory training, including FDA and ISO regulatory compliance and submission.
  • Quality training, including auditing, validation, design control, etc.
  • ASQ, RAPS, or other nationally recognized certification preferred.
  • Demonstrated experience in the preparation of regulatory submission applications such as (k), CE mark, Canada license, TGA registration, Brazil ANVISA applications, etc.
  • Experience may be considered in lieu of completed academic degree.
  • Experience with Design Control teams and other interactions with Engineering.
  • Experience with data analysis reporting.

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Regulatory Affairs Specialist • Seattle, WA

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