Urgent Hiring for Regulatory Affairs = W2 only

Fresher (or) Seniors can apply = W2 only == OPT, CPT,H1BT, EAD, GC, USC

Role: Regulatory Specialist II

Duration: 12 Months on W2

Shift Timings: 8 AM to 5 PM

Duties: Responsible for implementing and maintaining the effectiveness of the quality system.

Supports manufacturing/operations day-to-day activities for change control.

Provides consultation/advice to regulatory specialists for change control and product development.

Provides regulatory direction/interpretation on team activities.

Interprets and applies regulatory understanding to support products and teams.

Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.

Handles regulatory activities involved in documentation, labeling, and field support.

Applies regulatory and technical knowledge to a wide variety of complex work assignments. Maintains and ensures compliance with the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.

Ensures compliance with and demonstrates knowledge of site and division-level policies and procedures.

Years Experience: Must have 0-5 years of experience 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 Must. Bachelor’s degree in Science, Math, Engineering, or Medical Fields preferred.

Duties: This position will provide 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.

Thanks & Regards

Kiran Kumar | Senior Recruiter

Email: [email protected]

Desk Number: 732-412-6999 Ext 259

Direct Number: 732-398-6563

Website: www.intellectt.com

Address: 517 Route 1 South, Suite 1115 Iselin, NJ 08830

In my absence, you may contact Kowshik | Lead |

732-627-1210 | [email protected]