Contract opportunity through 7/8/2019
**Must be able to be a direct W2 of Three Point Solutions, Inc.**
Bachelors degree required
Local candidate needed to sit on site in Memphis:
Contractor will assess several print changes properly, assess changes of regulations and devices and update these design changes for other countries. Required to have an understanding of design change / manufacturing process changes and be able to meet with Product Design teammate. Candidate will be responsible to obtain OUS assessment on all changes. Candidate is responsible for US and EU assessments. The contractor will then summarize the world wide feedback and create a 1 page document with this information. Candidate will be using Agile and RAD (regulatory dB) on a daily basis.
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.
•Entry-level individual contributor on a project or work team.
•Works with close supervision.
•Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity:
•Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
•Makes minor changes in systems and processes to solve problems.
Communication and Influence:
•Communicates primarily with internal contacts within immediate group.
•Contacts others to gather, confirm and convey information.
Required Knowledge and Experience:
•Requires broad theoretical job knowledge typically obtained through advanced education.
•Bachelors degree required.
•0-1 years of experience required.
As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.
Role: Associate Regulatory Affairs Specialist 11219
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