Job Description
Regulatory Affairs Specialist II
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.
Company DescriptionA great company doing groundbreaking and important work with a great reputation in the industry!
A great company doing groundbreaking and important work with a great reputation in the industry!
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