Director of Regulatory Affairs - Austin, TX

Competencies 

• Proven Leadership Skills
• Intimate knowledge of Regulatory environment for medical devices, CFR, 13485. MDR
• Cost conscious, small company attitude
• Excellent communication and interpersonal skills
• Superior organizational and time management skills
• Sound decision making
• Ethical Conduct
• Close attention to detail
• Broad creativity and curiosity
• Effective problem-solving skills
• Adaptability, can work with changing priorities

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor’s degree in Science/Math/Engineering
• 10+ years’ experience in QA / RA in medical device manufacturing
• 5+ years of leadership experience
• 4+ years’ recent experience in CFR / ISO 13485 environment
• Audit experience with FDA and Notified Bodies
• Ability to understand and interpret customer needs; ability to work with all work functions (i.e. Regulatory, Operations, Human Resources, Engineering)
• Ability to work independently and lead in a team environment

Preferred Qualifications

• Masters’ degree in a related discipline
• Professional certification preferred (ASQ CQA, CQE, C Q. Mgr, CQA-Biomedical, RAC)

Supervisory Responsibility

This position has direct supervision. The individual may also be required to lead project teams and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.