Description

Position Summary: The Regulatory Compliance Coordinator will be responsible for reviewing and managing cases in the complaint handling system for completeness, compliance and accuracy. Additionally, the individual will be writing formal responses and communicating with customers (product owners). The Regulatory Compliance Specialist will support and assist the Regulatory Compliance Supervisor with daily tasks associated with Swiss American CDMO, LLC regulatory compliance.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Daily monitoring and follow-up on complaints and overall monitoring of initiation, investigation and approval of complaint records.
• Coordinate responses to failures including next steps, CAPA decision, report ability decision and trend analysis.
• Maintain knowledge; understand cGMPs and current regulatory expectations regarding complaint handling and reporting, trend analysis and overall Quality Systems.
• Lead and initiate communication to ensure quick responses to field complaints on a timely basis.
• Track and analyze field complaints to help resolve problems and improve the complaint handling process.
• Assuring complaint files are completed per the current process/SOP, timely evaluation of complaints within guidelines for the Quality Department and required regulations and standards are met.
• Effectively utilize several root cause analysis, data analysis and problem solving techniques such as 6M, Fishbone, Is/Is Not, 5WHYs, Statistical analysis with Qualitative and Quantitative data (variable and attribute data sets), Process Control Charts, Standard Deviation, Statistical Sampling Plans and AQL criteria as well as risk assessment methodologies etc.
• Participate in site post-market surveillance and pharmacovigilance activities.
• Assists in developing procedures to ensure regulatory compliance.
• Participates in the annual product review (APR) reporting writing process.
• Obtains regulatory certificates as requested (GMP, Certificate of Foreign Government, etc…)
• Facilitates the renewal process for state manufacturing licenses both inside and outside of Texas.
• Partner with the Quality Systems and Operations groups to establish and confirm compliance metrics for Quality Management Reviews.
• Completes annual design review for all medical device design files.
• Provides regulatory input into change controls and CAPA with limited scope to regulatory issues.
• Attends and participates in meetings as required.
• Attention to detail is critical.

Qualifications

Skills and Qualifications:

• Bachelor's degree or equivalent combination of education and experience 
• 3-5 years of related experience and/or training
• Skilled in applying root cause analysis techniques and statistical analysis for complaint trend analysis and problem-solving.
• Possesses a strong understanding of cGMPs, complaint handling regulations, pharmacovigilance, and quality systems.
• Proficient in initiating, investigating, approving, and maintaining complaint records according to SOPs and regulations.
• Excellent communication and interpersonal skills to lead and facilitate timely responses to complaints.
• Strong analytical and problem-solving skills to identify root causes and implement corrective actions.
• Ability to collaborate effectively with cross-functional teams (Quality Systems, Operations) to ensure compliance.
• Meticulous attention to detail for accuracy and adherence to procedures.
• Ability to participate in post-market surveillance activities (a plus).
• Experience with obtaining regulatory certificates (e.g., GMP) and state manufacturing license renewal (a plus).
• Proficient in Microsoft Office Suite & web tools.