Job Summary

The Regulatory Assistant will provide direct support to the Regulatory Manager in regulatory functions, to include but not limited to auditing, daily administrative tasks, and special projects.

Essential Functions

Job Responsibilities

• Participate in quality system and regulatory compliance audits.
• Provide assistance in planning and scheduling internal quality audits.
• Provide follow-up to department leaders for timely completion of audit findings.
• Assist Regulatory Manager with operational tasks.
• Other projects as assigned.
• Ensure and follow safety requirements and standards.
• Adhere to Ki Mobility’s Regulatory System requirements.
• Perform all duties in a manner that follows, demonstrates, and promotes Ki Mobility’s company values.
• Report to work as scheduled, on time, and able to work entire work schedule.
• Perform additional duties as assigned.

Knowledge, Skills, and Ability

• Ability to display strong professionalism and organizational skills.
• Ability to perform with highly developed attention to detail.
• Critical thinking skills with the ability to analyze and evaluate procedures and data to identify potential problems or areas of risk and draw accurate conclusions.
• Skill and ability to perform all essential functions in an ethical manner.
• Ability to maintain confidentiality and security of audit information.
• Intermediate level skills using computer applications (Word, Excel, enterprise software).
• Basic math proficiency.
• Possess effective written and oral communication skills.
• Able to work effectively both independently and within a team environment.
• Ability to be highly adaptable and responsive to changing business needs.
• Possess a continuous improvement mindset.
• Ability to observe and identify details.
• Ability to work extended hours as scheduled, including weekends.
• Ability to achieve Lead Auditor Certification is required.

Physical Demands

• Frequent sitting, wrist manipulation, walking, and standing.
• Frequent lifting and pushing up to 10 pounds.
• Occasional lifting and pushing up to 50 pounds.
• Manual dexterity to type and operate office equipment frequently.

Qualifications

Education

• High School Diploma or GED.
• Associate degree preferred.
• Quality Certifications such as ASQ-CQIA, CQI, CQPA, or CQT preferred.

Experience

• Required:
  • Manufacturing, mechanical, mechanical inspection, or machining experience.
  • Intermediate level experience with Microsoft Office programs (Word, Excel) and other enterprise software.
• Preferred:
  • Experience working in a Quality Management System controlled environment (ISO 13485, ISO 9001, TS 16949).
  • 2 – 3 years’ experience in an FDA regulated environment; preferably medical device.
  • Experience working in a quality position in a manufacturing environment.
  • Experience using mechanical inspection hand tools.

Working Environment

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the associate for this position. Duties, activities, and responsibilities may change, or new ones may be assigned at any time with or without notice. Associate must be able to satisfactorily perform the essential functions of the position with or without reasonable accommodations.

Ki Mobility is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.