Regulatory Affairs Specialist II

Description:


Provide Regulatory support in Manufacturing Plant Transition Project

Provide Regulatory Support in Quarterly Management Reviews

Provides regulatory expertise in any significant or non-significant changes

Support in maintaining and developing global regulatory strategies

Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Assist in PMS activities

Review and provide regulatory feedback on risk management plans/reports, Health Hazard Analysis, Adverse events by working cross functionally with Quality and Design team

Intiate, Review and Approve, NCMRs, CAPAs, Reworks etc

Reviews product and manufacturing changes for compliance with applicable regulations

Reviews protocols and reports to support regulatory compliance and submissions.

Assist in audit preps

Responsible for communicating with agencies for any Notification, Field actions, Adverse Events, Significant/Non-Significant Changes etc

Maintain Design Dossiers and Letter to Files

May provide assistance in processing pending invoices to any customers or agencies

Able to develop and maintain Risk Management,

What your background should look like:

Bachelor’s degree (BS, BA)

Currently have or perusing Masters in Regulatory Affairs

4 years' Regulatory experience.

Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

Ability to work effectively within a team in a fast-paced changing environment.

Multi Tasker and Quick Learner

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Education: High School