Regulatory Affairs Specialist II - First Shift

1 Year

Minneapolis, MN (Hybrid)

Max PR: $35-40/hr

NOTE: THIS IS A HYDRID ROLE. 3 DAYS OF THE WEEK THE TEMP WILL BE REQUIRED TO WORK ONSITE.

TEMP-PERM FOR THE RIGHT PERSON!

Required:

• Bachelor’s degree (BS, BA)

• Currently have or perusing Masters in Regulatory Affairs

• 4 years' Regulatory experience.

Job 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 wind-chill and assigned training

• Responsible for PSUR, CER, HHE, Impact assessments ( Post market surveillance activities )

• 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

• Initiate, 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,

Education & Qualifications

• 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.