Company: Job Juncture
Posted on: October 14, 2019
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.
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
Communicates with regulatory authorities and/or distributors to
prepare and submit documentation for marketing approval in all
Evaluates regulatory classification and provides regulatory
direction to product development team during design and
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
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
Reviews proposed product changes for impact on regulatory status of
Responsible for maintenance, and improvement of Training module of
the Document Control system compliant with FDA and ISO
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
Must show appropriate judgement and logic to show improvements to
the quality system, document control, and regulatory
Excellent written and verbal communication skills, and able to
utilize Adobe, Microsoft power point, Excel and Microsoft Word
Performs other duties that are reasonably assigned
- A Bachelor's degree in a scientific discipline is
- 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
Keywords: Job Juncture, Cleveland , Regulatory Specialist, Other , Mentor, Ohio
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