Regulatory Affairs Specialist

Indotronix Avani Group; Irvine (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

A staffing and recruiting firm is seeking a Regulatory Affairs Specialist to plan and implement regulatory submissions. Responsibilities include demonstrating knowledge of healthcare regulations, preparing submissions, and interacting with regulatory bodies to facilitate product approvals. The position is contract-based, suitable for someone at an Associate level of experience. Ideal candidates will possess skills to work independently with minimal guidance.

Qualifications

• Experience planning, coordinating, and implementing regulatory submissions for products requiring government approval.
• Working knowledge of healthcare-related regulations.
• Experience preparing regulatory submissions.
• Ability to translate data into reviewer-friendly content and interact with regulatory bodies.

Responsibilities

• Planning, coordinating, and implementing regulatory submissions for government approval.
• Working knowledge of healthcare-related regulations.
• Experience in preparing submissions and interacting with regulatory bodies.
• Translates technical data into reviewer-friendly content and interacts with regulators.
• Works independently, sets work priorities, and supports colleagues with less experience.

Job description

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.

Seniority Level

Associate

Employment Type

Contract

Job Function

Legal

Industries

Staffing and Recruiting