Regulatory Affairs/ RA/ Regulatory Specialist

24 Apr, 2022

Jobs

Regulatory Affairs/ RA/ Regulatory Specialist

Collabera
Arden Hills, MN

Description

Skills:

  • UK Regulations exp.
  • Regulatory Submissions writing
  • change control exp.
  • Class III or class II or AIMD exp.

 

Responsibilities:

  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
  • Monitors and improves tracking / control systems. Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.

Preferred Skills:

  • UK Regulations
  • Change control
  • Class III/Class II/AIMD
  • submission writing

Job details

Job ID
306149

Recruiter
Nandini
Email
nandini.rathore@collabera.com

Job posted: 2022-04-24