Katalyst CRO · 2 months ago
Regulatory Affairs Specialist
Seattle, WA
Contract
Onsite
Mid LevelKatalyst CRO is seeking a Regulatory Affairs Specialist to provide leadership on regulatory strategies and ensure compliance with government agencies. The role involves developing and filing applications for product sales, collaborating with project teams, and maintaining documentation for regulatory submissions.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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 U.S. FDA and applicable foreign regulatory bodies
Prepares and submits regulatory filings, such as FDA 510(k) and other domestic and foreign/Outside U.S. (OUS) regulatory filings, submissions, and trademarks
Prepares and maintains documentation (e.g., 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
Qualification
Required
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
Demonstrated experience in the preparation of regulatory submission applications such as 510(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
Preferred
ASQ, RAPS, or other nationally recognized certification preferred
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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