Regulatory Affairs Specialist - Onsite

Job Description

Regulatory Affairs is responsible for planning, coordinating and implementing regulatory Submissions for products that require government approval.

Demonstrated Skills

• 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

Experience

• 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
• Determines own work priorities
• Acts as a resource for colleagues with less experience