Regulatory Affairs Associate

ESSENTIAL DUTIES AND RESPONSIBILITIES

Adhere to the Company's Quality Management System to ensure compliance with applicable regulatory requirements.

• Perform tasks associated with the implementation and maintenance of the company's Quality Management System
• Provide support for regulatory affairs operations and administrative requirements
• Assist in SOP development by evaluating compliance with company policies and applicable regulations
• Support and perform tasks related to the company Corrective Action and Preventative Action (CAPA) compliance program
• Support and perform tasks related to overall supplier quality control
• Support and perform tasks related to the company audit program
• Support production activities and the transfer of product out of Quality control, ensuring that necessary documentation is generated and maintained
• Provide ongoing communication and regular status updates to senior management team
• Interface and collaborate with other departments, stakeholders, etc.
• Perform other duties as required

SUPERVISORY RESPONSIBILITIES

Direct Reports: Yes N/A

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Basic knowledge of ISO13485 and 21 CFR Part 820, Part 11
• Basic knowledge of Quality System Regulations ISO 14971
• Must be flexible and able to adapt to change
• Strong written and verbal communication skills
• Highly detail-oriented
• Communicates and works well with employees of all positions
• Computer literacy with standard software applications

EDUCATION AND/OR EXPERIENCE

• High school degree required
• Bachelor's degree preferred
• 1+ years of experience in a medical device manufacturing environment

CERTIFICATES, LICENSES, REGISTRATIONS

• ASQ certification preferred (e.g., Quality Engineer, Auditor, etc.)

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The work environment is an industrial setting dedicated to the production and assembly of medical devices that utilizes machinery, equipment, and specialized processes to transform raw materials into finished products. The work environment also includes a typical office setting.

PHYSICAL DEMANDS