Regulatory Operations Principal Specialist

• Support to Product Quality Management team:
•  Deliver technical reports fully in compliance with cGMP's
• Work with the team to execute risk management processes, procedures and documentation required to support quality risk management program. 
•  Providing quality oversight to new combination product development as well as lifecycle management.
• Collaborate and build trusting relationships with all stakeholders and business partners in identifying opportunities for improvement and meeting goals and objectives. 
• Collaborate on data driven risk assessments (risk identification, analysis and evaluation) and formulate risk mitigation plans as well as support Corrective and Preventive Action (CAPA) plan initiatives. 
• Executing the functions as called out in Standard Operating Procedures.
• Coordination of documents in the document management system.
• Be accountable to assure quality & compliance with procedures and customer requirements.
• Identify potential issues, perform trouble shooting, resolve conflicts and provide solutions for technical documentation related activities, coordinate the issues in a timely manner.

Learn more about our EEO & Accommodations request here.