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Regulatory Affairs/ RA/ Regulatory Specialist
Arden Hills, MN
- UK Regulations exp.
- Regulatory Submissions writing
- change control exp.
- Class III or class II or AIMD exp.
- 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.
- UK Regulations
- Change control
- Class III/Class II/AIMD
- submission writing
Job posted: 2022-04-24