Regulatory Affairs Specialist

Summary

Regulatory Affairs SpecialistResponsibilitiesRegulatory 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 LevelAssociateEmployment TypeContractJob FunctionLegalIndustriesStaffing and Recruiting#J-18808-Ljbffr

Job Description

Regulatory Affairs SpecialistResponsibilitiesRegulatory 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 LevelAssociateEmployment TypeContractJob FunctionLegalIndustriesStaffing and Recruiting#J-18808-Ljbffr