Regulatory Specialist II

Job Description

· 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.

· 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.Company Description

Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.