Indotronix Avani Group
Regulatory Affairs Specialist
Indotronix Avani Group, Irvine, California, United States, 92713
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
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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
#J-18808-Ljbffr