Regulatory Compliance Analyst

Please note I have direct access to the Hiring Director of Regulatory Compliance on this position. 

We are an International, successful, extremely profitable and the largest global privately held medical software/hardware Company looking for a Regulatory Compliance Analyst. We are privately held, has been in business for 65+ years, has $1+ Billion in revenue, have 5K+ employees, are extremely profitable and have never laid-off an employee.

The Regulatory Compliance Analyst will work alongside Global R&D, Product Management, Manufacturing Engineering, Quality Management and Regulatory affairs in providing support and guidance regarding regulatory compliance as it pertains to Class II and Class III medical devices. More specifically, the Regulatory Compliance Analyst will:

• Conduct systematic internal audits of the company's Quality Management Systems (QMS) in relation to requirements found in ISO 13485:2003, the FDA Quality System Regulations and any other applicable requirements. Facilitate the definition, assignment, and closure of corrective actions. Report audit results and corrective action progress to management. 
• Ensure that the QMS is properly constructed and maintained according to applicable global standards.
• Interpret FDA, ISO, and CSA regulations and develop company compliance that satisfies ISO 13485, the Canadian Medical Device Regulations, and the U.S. FDA cGMP/QSR. 

• Ensure that the QMS continues to improve in alignment with new or revised applicable regulatory requirements standards, specifically ISO 13485

• Prepare for, support, and resolve corrective actions for external audits by FDA, Notified Bodies, and other regulatory agencies.

The Regulatory Compliance Analyst reports to the Director of Regulatory Compliance.

Requirements

• Must have experience performing compliance with ISO 13485 for QMS for Class II and Class III medical devices.
• Bachelor’s degree in Toxicology, Chemistry, Chemical Engineering, Material Science, Engineering, or related degree
• It would be a plus (not mandatory) to have any working knowledge of standards and regulations such as: ISO 9001, FDA Quality System Regulation 21CFR Part 820, and/or QMS Software

Benefits

We offer full benefits (PPO & HMO) including dental and vision, matching 401K, 3 weeks of paid vacation, 10 paid holidays, paid sick days, Short and Long-Term Disability, Life Insurance, Tuition reimbursement, casual dress, and flexible work hours that all start upon employment.