Regulatory Affairs Specialist

Overview

Position:
Regulatory Affairs Specialist

Location:

Sparks, MD

Duration: 3+ Months Contract

Total Hours/week: 40.00

1st shift

The Individual will work with global colleagues to support Korea, China, and/or other countries as they fulfill requirements to register products. 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

• 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
• 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