Regulatory Affairs Specialist II - The Panther Group
Plymouth, MN 55441
About the Job
The Panther Group is looking for a Regulatory Affairs specialist with 4+ years of experience just outside the Minneapolis area in a manufacturing facility. This is a temp to hire role for the right person and this person needs to be willing to work a Hybrid schedule, 3 days/week on-site.
Job Description:
Shift: Monday-Friday, 8AM-5PM
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 the PDM (Windchill) 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,
Background:
Bachelors 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.
Job Description:
Shift: Monday-Friday, 8AM-5PM
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 the PDM (Windchill) 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,
Background:
Bachelors 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.
Source : The Panther Group
