Regulatory Affairs Specialist II at Randstad USA

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.