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Regulatory Specialist

Company: Job Juncture
Location: Mentor
Posted on: October 14, 2019

Job Description:

Job Summary
The Regulatory Affairs Associate is an integral part of the Quality and Regulatory team. The associate will be responsible for maintaining regulatory compliance via registrations, document control, being part of the internal and external audit team, analyzing data, reporting trends, and coordinating CAPA facilitation. In addition, the specialist will provide regulatory support to product development, quality, and production with respect to design, process, and quality concerns.
Essential Skills:
Performs research, distribution, storage, tracking, and retrieval of relevant information/documents pertinent to the regulatory registrations and submissions.
Evaluates the local and global regulatory environment and assists in providing strategies throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance and prevent any regulatory obstacles.
Authors, reviews, and publishes paper and electronic submissions and communicates with regulatory authorities and government agencies.
Communicates with regulatory authorities and/or distributors to prepare and submit documentation for marketing approval in all markets.
Evaluates regulatory classification and provides regulatory direction to product development team during design and development.
Develops and evaluates risk of potential regulatory strategies for new and modified products by performing research and analysis in both new and sustaining markets.
Provides regulatory information and guidance for proposed product claims/labeling
Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation.
Helps train stakeholders on current and new quality and regulatory requirements to ensure organization-wide compliance.
Assists other departments in the development of SOPs to ensure regulatory compliance.
Reviews proposed product changes for impact on regulatory status of the product.
Responsible for maintenance, and improvement of Training module of the Document Control system compliant with FDA and ISO requirements.
Prepare/record changes to controlled documents including formatting, review and confirm changes with relevant departments, prepare training material, and coordinate with users to ensure electronic document processing is complete and document control is maintained and effective.
Ensure documents and records meet quality standards and maintain onsite and offsite document storage.
Analyzes data, tracks and trends quality metrics, and develops solutions as needed for management review.
Complies with regulatory requirements of the FDA, Health Canada, European Union, Japan, and any other regulations of target markets.
Must show appropriate judgement and logic to show improvements to the quality system, document control, and regulatory compliance.
Excellent written and verbal communication skills, and able to utilize Adobe, Microsoft power point, Excel and Microsoft Word effectively
Performs other duties that are reasonably assigned
Job Requirements:

  • A Bachelor's degree in a scientific discipline is required.
  • Regulatory affairs experience in a medical device environment and comprehensive understanding of applicable FDA and ISO regulations with RAPS/RAC certification is preferred.
  • Travel - Estimated travel is less than 20%, on an as-needed basis

Keywords: Job Juncture, Cleveland , Regulatory Specialist, Other , Mentor, Ohio

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