The individual will support registration of in vitro diagnostic assays by reviewing and approving verification study reports, package insert / labeling, Technical Files and other documents, and submitting documentation on schedule as directed
As an individual contributor; the function of a Regulatory Affairs Associate is to provide support for regulatory processes and procedures. The individual may execute tasks and exercise influence generally at the peer level.
Core Job Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function may include:
Assist in SOP development; review and initiation
Stay abreast of regulatory procedures and changes in regulatory climate and update department
Investigate regulatory history of similar products to assess approval implications
Assist in monitoring and reporting project timelines
Respond to regulatory information requests
Monitor and utilize tracking and control systems
Organize materials from preclinical and clinical studies for review and assist in review process
Compile and organize materials for pre-submission reports
Coordinate and assist in the preparation of submission/registration packages
Coordinate registration requests and track completion
Oversee quality control of regulatory documents and submissions
Organize meetings with regulatory agency staff
Update and maintain global product listings; facility registrations; licenses/approvals; and annual registrations
Assist in the preparation of routine reports and regulatory agency communications
Update and maintain paper/electronic document archival systems
Prepare legal documents for import/export; registrations; tenders/bids or other purposes
Assist with review of promotional items
Coordinate internal audits and inspections
Assist with global vigilance reporting and regulatory field actions such as recalls or corrections & removals
Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
Individuals coordinate and support technical and scientific regulatory activities; research regulations and guidance; and maintain and organize key information sources. Individual works under general supervision; receives limited supervision on standard issues; and detailed instructions on new assignments. Work is reviewed for soundness of judgment; overall adequacy and accuracy.
Bachelors degree (or equivalent); Bachelors degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred.
This position does not require previous regulatory experience. 2 years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area Background / Skills / Knowledge Regulatory Knowledge of (as applicable) Regulatory history, guidelines, policies, standards, practices, requirements and precedents Regulatory agency structure, processes and key personnel Principles and requirements of applicable product laws Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs) Principles and requirements of promotion, advertising and labeling Note: This knowledge may be developed through tenure in this position. Communication Skills or Ability to: Communicate effectively verbally and in writing Learn to write and edit technical documents Work with cross-functional teams Work with people from various disciplines and cultures Cognitive Skills or Ability to: Pay strong attention to detail Handle detailed tasks and prioritize them Meet deadlines Think analytically and critically Review and analyze documentation Research and locate information on regulatory requirements and products Exercise judgment within defined procedures and practices to determine appropriate action Has general knowledge of technical alternatives and gain an understanding of their impact on the systems environment Apply business ethical standards
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