Regulatory Admin Coordinator

We're seeking an Office Manager for one of our clients in Lompoc, CA. This is a full-time temporary assignment, lasting 2 to 3 months, with a pay range between $22 and $25 an hour. The schedule is Monday through Friday, 8AM to 5PM. If you're interested in this role, apply today! We'd love to see your resume! •This position requires a federal drug test (including marijuana) and background check•Duties & Responsibilities Assist Regulatory in generating and compiling regulatory submissions. Coordinate all aspects of regulatory projects, and document regulatory processes to ensure regulatory compliance. Assist in editing regulatory documents in preparation for final submissions. Provide tactical and logistical Regulatory support for new registration of products or licensing and renewals of existing registrations and/or licensing. Coordinate department projects, meetings, and conferences both internal and outside with other departments, regulatory agencies, partners, and consultants. Coordinate shipping of all regulatory submissions. Maintain regulatory databases and files; input data and archive as needed. Organize and retrieve submissions from regulatory archives. Perform research activities, as directed. Support Regulatory staff with Regulatory Affairs communications files, as needed. Assist in redaction projects, regulatory requests for historical and current documents, in generation of certificates for international registrations, and with other miscellaneous projects, as directed. Utilize inventory system (PRMS/LX) to locate information, such as manufacturing dates; as well as to revise PRMS/LX listings for kit builders, according to current instructions. Adhere to all applicable quality system procedures and work instructions. Prepare engineering change requests (ECR), master kit builders, and drawings as directed. Organize and compile intra-company documentation requests. Demonstrate the highest level of professionalism, accountability, work ethic and follow through at all times. Develop and maintain productive and effective relationships with peers, superiors and quality and regulatory authorities. Represent the company in a positive and supportive manner at all times Work with quality and regulatory staff to determine, execute, and review appropriate data management practices for assigned projects. Review art department literature, creating or changing kit builders and the drawings associated with them as directed. Propose more efficient documentation procedure methods as appropriate and provide accurate information is a prompt manner. Participate on and attend project teams meetings as assigned or required. Perform other duties as assigned Skills & Qualifications Associate's degree in Business Administration or related field; and five to seven years relevant experience or combination of education and experience. Knowledge of FDA QSR's and U.S. Food, Drug, and Cosmetic Act as amended. Knowledge of

ISO 13485, ISO

9001, Medical Device Directives and Health Canada (CMDR) requirements. Knowledge of medical device manufacturing or a related field. Skill in demonstrating a professional phone manner. Ability to effectively prepare regulatory documents including editing, proofreading, and layout. Ability to take initiative, be a self-starter, learn quickly and retain information and able to able to work well with minimal instruction and supervision. Ability to establish and maintain moderately complex documentation systems. Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts. Ability to accurately perform detail oriented work. Ability to be flexible in changing daily workload priorities as directed. Ability to maintain accuracy, consistency and quality in a fast-paced, multi-task environment. Ability to coordinate and synchronize multiple projects. Ability to function in a controlled environment under domestic and international regulations and handle extremely confidential data. Ability to travel for business, including overnight stays. Ability to use MSWord, Excel, FileMaker Pro and Powerpoint, Filemaker Pro and operate various office machines, including FAX and photocopier. We provide equal employment opportunities in hiring, promotion, transfer, compensation, benefits, and all other employment decisions. These opportunities and other conditions of employment are extended to qualified applicants and employees without regard to an individual's ancestry, race, color, religious creed, sex, pregnancy, genetic information, sexual orientation, gender, gender identity (including transgender) or expression, age, marital status, medical condition, mental or physical disability, national origin, citizenship/immigration status, military or veteran status, or any other protected status under applicable laws.

Pay:

$22.00 - $25.00 per hour People with a criminal record are encouraged to apply

Work Location:

In person