Sr. Product Complaint Specialist

Job Title: Sr. Product Complaint Specialist

Supervisor: Associate Director, Regulatory Affairs

Strategic Focus Areas:

  • Perform all activities within the requirements of the Quality System and 21 CFR Part 820 and 211, ISO 13485, EU Council Directive 93/42/EEC
  • Participate in projects and activities which support the market expansion efforts of the Company
  • Maintain cost discipline within assigned programs

Specific Tactical Responsibilities:

  • Responsible for initial customer contact for customer product related complaints; act as single point of contact for customer during complaint process
  • Initiate complaint investigations, provide an official initial evaluation and communicate with other departments to facilitate proper investigation
  • Recommend resolution for each complaint and ensure complaints are closed in compliance with Anika procedures
  • Ensure proper corrective action is taken as directed in the complaint resolution
  • Communicate appropriate complaint data and instances to management, as needed
  • Responsible for performing trend analysis, writing respective reports, and presenting the complaints data to management as required
  • Maintain accurate complaint database and prepare reports, metrics, trends, and graphs; ensure complaint files and cabinets related to area of responsibility are orderly and complete
  • Maintain current knowledge base of existing and emerging regulations, standards and guidance documents
  • Support the preparation of new marketing applications for submission to domestic and international regulatory authorities
  • Support RA sustaining activities (annual reporting, product changes, etc.)
  • Perform internal audits, as assigned
  • Perform any other duties or responsibilities as assigned

 Job Complexity:

The position works on complex issues which require data gathering and analysis. The position interacts with other departments in order to achieve results. Errors, omissions or inaccurate/incomplete recordkeeping can have significant negative impact on the organization. This role will also support the preparation and filing of regulatory submissions with a varying degree of complexity.

Required Qualifications:

  • Bachelors’ degree in the life sciences or related field or previous relevant experience
  • Knowledge and understanding of GMP/ISO regulations, including but not limited to 21 CFR Part 820 and 211, ISO 13485, EU Council Directive 93/42/EEC
  • Must have excellent communication and organizational skills

Desired Experience, Knowledge, and Skills:

  • Minimum 5 years’ experience in the medical device, biologic, or pharmaceutical industry is preferred. Two or more years pre/ post-market regulatory experience is a plus.
  • Advanced knowledge and experience with global post-market surveillance activities and reporting requirements.
  • Experience preparing regulatory submissions (domestic and international) for medical devices or pharmaceuticals
  • Ability to interact positively and professionally with customer
  • The ability to communicate effectively across disciplines, gather information and perform analysis
  • Ability to evaluate and interpret the data and write conscious reports
  • Proficiency in word processing, spreadsheets and databases
  • Good presentation, organization and communication skills
  • Ability to work autonomously, effectively manage time and deliver results on time

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