Job Information
Actalent Regulatory Affairs Specialist in Plymouth, Minnesota
Description:
Support daily Regulatory Affairs function eg compliance to 21 CFR 820807803 ISO 13485 requirements Company policies operating procedures processes promotional task assignments into 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.
Qualifications:
Bachelors degree BS BA.
Currently have or pursuing 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.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.