Regulatory Affairs Specialist

Regulatory Affairs Specialist Responsibilities

• Regulatory Affairs is responsible for planning, coordinating and implementing regulatory submissions 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 ensure that the appropriate regulatory requirements for the submission are met; interacts with regulatory bodies 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.

Associate

Contract

Legal

Staffing and Recruiting