Senior Requlatory Affairs Specialist

Department: RegulatoryClinical
Reports to: Regulatory Affairs Manager

Ensures compliance to FDA and other applicable regulations. Prepares, analyzes, and submits dossiers to various governing agencies in supporting business growth. Supports applicable regulations including ISO, local, state, and/or federal requirements. Coordinates collection of information and documentation and compiles into submissions, license renewals, periodic updates and registrations to regulatory agencies worldwide. Organizes regulatory information and logs, tracks and controls submissions. Reviews and advises on labeling, protocols, development and manufacturing documents for compliance with regulatory requirements. Reviews and advises on product changes for impact on regulatory filings worldwide. Researches regulatory issues and provides guidance and advice to colleagues. Reviews complaints for incident reporting.

1. Prepare, review and file appropriate regulatory documentation to ensure devices are commercially available: preIDEs, IDEs, 510(k)s, PMAs and PMA Supplements. 2. Compile materials for license renewals, updates and registrations. 3. Maintain regulatory files/databases and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners. 4. Review labeling for compliance with regulatory requirements. 5. Reviews and advises on manufacturing batch records, product specifications, validation reports and other DHF records to ensure compliance. 6. Maintain current knowledge of international regulations, guidances and standards applicable to Anika products. 7. Support the Design Control Process - Research regulatory issues and disseminate regulatory information to Production, QA,QC and R&D departments and senior management. 8. Review complaints for potential MDR, MDPR, and vigilance reporting. 9. Review DCRs and Change Controls for regulatory compliance and possible submission. 10. Stay current on changes in regulations and agency guidance. 11. Review clinical protocols to be used in submissions. 12. Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management. 13. Document, consolidate and maintain oral and written communication with FDA and other notified bodies. 14. Prepare rational to file documentation for modifications to devices when appropriate. 15. Participate in FDA & other notified body Inspections. 16. Author and/or review regulatory procedures and update as necessary. 17. Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information. 18. Other duties and responsibilities as required.

1. Requires BA degree in a health, science or related field. 2. 5 to 7 years relevant experience in regulated environments. 3. International experience is a plus. 4. Requires creative, problem-solving ability and excellent oral and written presentation skills. 5. Requires proficiency with standard software Microsoft Office Suite, Project, etc.