Job Description :
Position: Regulatory Affairs Specialist
Location: West Chester, PA or Cincinnati Ohio
Duration: 12+ Months

The Regulatory Affairs Specialist – Product works within a team of Regulatory Affairs professionals to ensure MANUFACTURER establishes best practices in the area of premarket regulatory submissions and new product development.

Key responsibilities include:
File and maintain regulatory deliverables.
Create the regulatory compliance / project plan using Regulatory Intelligence and in collaboration with Region RA to ensure all requirements are met for country submissions; work with relevant personnel to ensure appropriate, timely input is provided for submissions.
Create and file submissions; communicate with authorities regarding these submissions.
Communicate license approvals when received.
Complete specific country testing and work with Region RA, and arrange for test devices and support as needed.
Review and approve advertising and promotion material ensuring it is consistent with approved claims for regulated products.
Review changes in existing products to determine need for new/revised submissions or document reason for no submission
Communicate changes in existing products to Region RA for determination of the need for new/revised licenses or registrations; partner with Region RA for countries with license expiration requirements; establish plan and deliverables for timely submission for renewal of license.
Identify any clinical data requirements for product licensing globally and insure the requirements are documented in the compliance plan.
Provide RA oversight to clinical studies.

Required Qualifications:
Bachelor’s Degree (or international equivalent) in a related field such as: Regulatory Science, Biomedical Engineering, Mechanical Engineering OR minimum of 4 years progressive regulatory affairs experience in medical device or medical product regulation agencies, including knowledge and experience applying drug or device laws and regulations
Experience in a medical device industry. (Orthopedics industry is preferred)
Knowledge of Quality Management Systems (QMS) & Quality Regulatory System (QRS
Experience working across cultures/countries/sites.
Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc and standards bodies such as AAMI, IEC, ISO, UL.