Regulatory Compliance Specialist

2 weeks ago

Santa Clarita, California, United States CC Wellness Full time
{"title": "Regulatory Affairs Assistant", "description": "About CC Wellness

CC Wellness is a rapidly growing California-based pharmaceutical company focused on delivering personal care and intimate wellness products in a socially responsible manner through science-based innovation and world-class manufacturing.

We believe that even the smallest choices in life can lead to big changes. Like a ripple resonating from a single raindrop, the impact you make today can transform someone's wellbeing tomorrow.

Job Summary

The primary purpose of this position is to support the company's regulatory compliance efforts by conducting research, analysis and review, preparing filings, reports, minutes and communications and assist with day-to-day functions that are handled within the Regulatory Department.

Key Responsibilities
  • Assist in creating and maintaining Design History Files, Device Master Records, and Technical Files
  • Understand and learn all of the regulations that apply to medical devices
  • Write and produce technically written forms and SOPs that comply with regulatory requirements and institutional policy
  • Ensure compliance documents satisfy federal, state, and local government requirements
  • Maintain Regulatory databases and the filing system and internal trackers to support internal audits and recall activities and interface with cross-functional personnel, as required
  • Provide support to internal team members in relation to compliance-based questions and/or requests
  • Demonstrate ability to interact in a positive, respectful manner and establish and maintain cooperative working relationships
  • Display excellent customer service to meet the needs and expectations of both internal and external customers
  • Exhibit excellent listening and interpersonal communication skills to identify critical core competencies based on success factors and organizational environment
  • Effectively organize, prioritize, multi-task and manage time
  • Demonstrate accuracy and productivity in a changing environment with constant interruptions
  • Analyze information, problems, issues, situations and procedures to develop effective solutions
  • Exercise strict confidentiality in all matters
Requirements
  • Bachelor's degree from a four-year college or university
  • Or one to two years related experience
  • And/or training or equivalent combination of education and experience

CC Wellness is an equal opportunity employer of protected veterans and individuals with disabilities. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of disability or their protected veteran status.

", "lang_code": "en"}

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