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Regulatory Specialist II

Santa Clara, CA 95054

Posted: 11/29/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 593045 Is job remote?: No Country: United States

Job Description

Duties: This position will be providing support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions and suppliers. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

Years Experience: Must have 3-5 years of experiences in Medical Device Regulatory Affairs Skills: Have working knowledge in EU MDR Have working knowledge in Regulatory Change Assessment in Have working knowledge in US and EU medical device submissions Have experience supporting internal and external inspections Work cross-functionally and in a matrixed environment Have experience with continuous improvement activities

Education: BA Degree Required. Bachelor’s degree in Science, Math, Engineering or Medical Fields preferred.

?target pay: 50-56/hr
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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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