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Regulatory Affairs Project Manager

Company: Meissner Filtration Products, Inc.
Location: Camarillo
Posted on: September 22, 2022

Job Description:

SummaryAre you looking to apply your Regulatory experience in a high-impact position, doing positive work for humanity? If so, wed like to hear from you! An ideal candidate would help tackle the demands of global pharmaceutical clients with a combination of knowledge, training, and discernment.Essential Duties and ResponsibilitiesDuties and responsibilities include the following. Other duties may be assigned.

  • Assist with overseeing regulatory compliance for the organization ensuring high reliability from our customers.
  • Respond to complex client inquiries utilizing clear, concise, and technical writing skills.
  • Assess compliance by assisting in scheduling and monitoring activities related to Sterilization Validation, conducting audits, analyzing and verifying documentation, reviewing process changes and SOPs.
  • Comfortable meeting with clients to explain and respond to questions regarding Meissners Regulatory program.
  • Assist in the development, implementation, maintenance, and performance of the companys Quality Systems and maintaining Meissners Drug Master Files.
  • Coordinate with other Meissner teams when Regulatory expertise is needed to complete projects and provide regulatory excellence throughout the organization.
  • Improves compliance by recommending and following-up on improvement plans and contributing information to cross-functional quality improvement teams.
  • Complete client-requested Regulatory documentation and develop processes to assure effective communication with customers.
  • Prepare regulatory /quality assurance reports by collecting, analyzing, and summarizing data and trends as requested.
  • Report and communicate customer complaints on quality system problems, customer feedback following audit and product quality to the appropriate functional departments.
  • Support quality audits of external vendors. Some travel may be required.Qualifications, Education & ExperienceThe requirements listed below are representative of the knowledge, skill, and/or ability required to successfully function in this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
    • Bachelors Degree from a 4-year accredited college or university.
    • Minimum 2-3 years working in experience in a Regulatory function.
    • Experience with cGMP regulations, production operations and laboratory operations preferred.
    • Effective written, verbal and presentations skills.
    • Ability to support multi-level and multi-discipline work teams to develop, manage processes/business systems.
    • Diligent follow-through and ability to handle multiple tasks.
    • Strong knowledge of software including MS Office suitePhysical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee frequently is required to walk and sit. The employee is occasionally required to stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.These duties will be performed predominantly in an office environment, though on occasion, the employee may be required to work with production in an ISO Class 7 cleanroom environment. Powder free gloves, face masks, hairnets, gowns and shoe covers must be worn. Shorts, loose or baggy clothing is not permitted. Makeup, other than skin moisturizers, is not permitted. Because smokers continue to shed thousands of smoke particles even hours after smoking a cigarette and these particles will damage our products, only non-smokers are permitted to enter or work in the cleanroom. Each employee of the Company is an at-will employee, unless specifically notified otherwise in writing. This means that the terms and conditions of employment may be changed with or without cause. It also means an employee may terminate their employment at any time, for any reason, and the Company has the same right to terminate an employees employment at any time for any reason.Meissner Filtration Products is Proud to be an Equal Opportunity Employer.Requisition ID: 2022-1301 External Company URL: Street: 1001 Flynn Road Remote Work: No

Keywords: Meissner Filtration Products, Inc., Camarillo , Regulatory Affairs Project Manager, Executive , Camarillo, California

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