RAD Analyst

Proclinical is currently advertising a vacancy for a RAD Analyst with one of the world's largest workforce management solution companies. This company, which specialises providing management in multiple scientific and engineering sectors, is looking for a hard-working individual to join their Massachusetts based team on a contract role.

The RAD Analyst will enter product approval requests into the buyers Product Registration 'Regulatory Approval Database (RAD) to enable product release to World Wide Markets, whilst maintaining completely regulatory compliance. RAD Analysts receive RAD Processing Packages from RAD Investigators and execute the entry and validation of approval data into the RAD system. They will also act as a secondary review of the approvals.

Job Responsibilities:

• Updating request tracking processes to ensure workload and status is documented.
• Entering, maintaining, and validating regulatory approvals in the RAD system.
• Providing secondary review of approval requirements during data validation.
• Performing special projects as required.
• Assisting RAD Investigator with approval investigations as required.
• Performing other duties as assigned.

Skills and Requirements:

• A Bachelor's degree.
• At least 2+ years of regulated industry experience is required.
• A basic working knowledge of FDA and/or European regulatory requirements is required.
• Demonstrable experience with 510Ks, Technical Files, PMAs, and design dossiers is preferred.
• Experience with US and EU Regulatory requirements is preferred, with international experience outside of the two an asset.
• The ability to develop and maintaining excellent working relationships with regulatory personnel is required.
• An ability to write, proofread, and check documents for accuracy; an ability to relate information to requirements, and an ability to identify inconsistencies will be needed.
• Proficiency in the use of technology, including MS Office.
• Excellent communication, organisational, and problem-solving skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Maya Smith on + 44 267-405-6995 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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