Regulatory Affairs, Specialist III
Role:
Regulatory Affairs is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval.Demonstrates working knowledge of healthcare-related regulations
Demonstrates in-depth knowledge of preparing a submission
Demonstrates in-depth knowledge of industry and competitive products
Applies relevant regulations and statutes to further product submissions of basic to medium complexity
Contributes to the strategic direction of regulatory pathway development
Refines and conforms the preliminary data used in the submission process
Translates technical data and descriptions into reviewer-friendly content
Helps to ensure that the appropriate regulatory requirements for the submission are met
Interacts with regulatory body to help further product approvals or clearance
Has in-depth experience, knowledge and skills in own job family
Applies knowledge and skills to a wide range of standard and non-standard situations
Works independently with minimal guidance
Usually determines own work priorities
Acts as a resource for colleagues with less experience Requirements:
Must have experience with WindChill ?Pay $45-55 based on experience level
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