Specialist - Regulatory Affairs - Operations 4A

The Complaints Analyst is responsible for reviewing complaint records. This role performs detailed complaint assessments, completes missing documentation, supports investigations, and ensures complaint files are accurate, complete, and audit ready. The analyst works closely with Quality, Regulatory Affairs, and subject matter experts to resolve gaps and maintain project timelines. In addition, the role documents all activities and supports the preparation of metrics and reports for management and regulatory review. Day to Day Responsibilities:

• Review complaint records
• Assess complaint files for missing documentation, approvals, or required actions.
• Complete and document activities in ETQ.
• Support the completion of missed investigations and follow-up activities.
• Complete decision trees for MDR reporting to determine reportability for US and EMEA and APAC
• Complete Medwatch forms and submit to aligned Health Authoritis
• Gather and attach supporting documentation to complaint files.
• Ensure complaint records comply with SOPs and regulatory requirements.
• Coordinate with Quality, Regulatory Affairs, and product SMEs to resolve questions.
• Document findings and actions in project tracking tools.
• Escalate potential patient safety or regulatory concerns to management.
• Participate in team calibration sessions to ensure consistency across reviewers.
• Meet daily and weekly to review productivity and quality targets.
• Maintain complete and audit-ready documentation for all activities.
• Provide status updates and support the preparation of project metrics and reports.

KNOWLEDGE, SKILLS AND EQUIVALENT EXPERIENCE

• Associate degree in science or related field of study
• Related experience within the pharmaceutical industry. Will consider an

advanced degree in lieu of years of experience.

• Strong Verbal and Written Communication Skills in English
• Problem Solving Skills
• Adept at Attention to Detail
• Strong understanding of Good Documentation Practices
• Good organizational skills
• Analytical skills
• Self-motivated/directed
• Computer literate—proficient in use of word processors. Must be able to

understand and utilize complaint database software and reporting tools.

• Knowledge of cGMPs and Code of Federal Regulations regarding drugs, medical

devices, combination products and biologics

• Project and Time Management Skills
• Interpersonal skills-must be proactive, personable, flexible, team-oriented
• Customer Service Skills
• Ability to multitask in a highly stressful environment
• Ability to operate in a constantly changing environment