Job Information
Randstad US regulatory affairs specialist ii in minneapolis, Minnesota
regulatory affairs specialist ii.
minneapolis , minnesota
posted september 6, 2024
job details
summary
$38 - $40.72 per hour
contract
bachelor degree
category life, physical, and social science occupations
reference48838
job details
job summary:
As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!
location: Minneapolis, Minnesota
job type: Contract
salary: $38.00 - 40.72 per hour
work hours: 9 to 5
education: Bachelors
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,
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.
skills: CAPA, Regulatory Affairs Operations, Regulatory Affairs Strategy
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Randstad US
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