Job Title Synonyms

Job Description

Job Title: Regulatory Specialist II

Duration: 12 months

Shift: 8 am - 5 pm

Location: Santa Clara, CA - 95054

Pay rate starts from $42 /hr.

Skills:

Have working knowledge in EU MDR Have working knowledge in Regulatory Change Assessment

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.

Must have 3-5 years of experiences in Medical Device Regulatory Affairs

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.