REGULATORY AFFAIRS SPECIALIST III

Job Overview

Regulatory Affairs oversees compliance activities for customers. This covers reporting, tracking and improving compliance with regulations and laws pertaining to the manufacture, marketing and development of regulated products.

Responsibilities:

•    Support daily Regulatory Affairs function eg; compliance to 21 CFR 820,807,803 ISO 13485 requirements, Company policies, operating procedures, processes, promotional task assignments into windchill and assigned trainings
•    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, DFM, Process Validation, Product life cycle review.

Candidate Desired Profile:

•    Bachelor’s degree (ME, BE) 
•    Currently have or perusing Masters in Regulatory Affairs
•    7 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.

Competencies