Product Regulatory Compliance Specialist
Artech, Westbrook, ME, United States
Introduction
We are seeking a dedicated and detail-oriented professional to ensure our products meet regulatory compliance standards across multiple regions. The successful candidate will be responsible for coordinating regulatory documents, managing submissions, and ensuring compliance with local and regional registration requirements. Required Skills & Qualifications
Good analytical skills Ability to learn systems Intermediate Excel skills (ability to use formulas and create pivot tables) Focus on accuracy in data review and processing, reporting & declarations for multiple countries, schemes, and time periods Organized in generating and organizing a large number of files and documentation Prior work experience at client or in client's Industry
Applicants must be able to work directly for Artech on W2 Preferred Skills & Qualifications
Experience with some company ERP systems (e.g., SAP) Experience generating standard reports out of systems
Day-to-Day Responsibilities
Coordinate regulatory documents, ensuring that submissions are timely and regulatory objectives are met Research scientific and regulatory information to write, edit, and review reports Compile all materials required for submissions, license renewals, and annual registrations Keep informed of professional and global regulatory information Work with governmental regulatory agencies Perform the coordination and preparation of document packages for regulatory submissions for new and mature products Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance Monitor and improve tracking/control systems Keep abreast of regulatory procedures and changes Potentially direct interaction with regulatory agencies on defined matters Recommend strategies for earliest possible approvals of clinical trials applications
For immediate consideration please click APPLY to begin the screening process with Alex.
We are seeking a dedicated and detail-oriented professional to ensure our products meet regulatory compliance standards across multiple regions. The successful candidate will be responsible for coordinating regulatory documents, managing submissions, and ensuring compliance with local and regional registration requirements. Required Skills & Qualifications
Good analytical skills Ability to learn systems Intermediate Excel skills (ability to use formulas and create pivot tables) Focus on accuracy in data review and processing, reporting & declarations for multiple countries, schemes, and time periods Organized in generating and organizing a large number of files and documentation Prior work experience at client or in client's Industry
Applicants must be able to work directly for Artech on W2 Preferred Skills & Qualifications
Experience with some company ERP systems (e.g., SAP) Experience generating standard reports out of systems
Day-to-Day Responsibilities
Coordinate regulatory documents, ensuring that submissions are timely and regulatory objectives are met Research scientific and regulatory information to write, edit, and review reports Compile all materials required for submissions, license renewals, and annual registrations Keep informed of professional and global regulatory information Work with governmental regulatory agencies Perform the coordination and preparation of document packages for regulatory submissions for new and mature products Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance Monitor and improve tracking/control systems Keep abreast of regulatory procedures and changes Potentially direct interaction with regulatory agencies on defined matters Recommend strategies for earliest possible approvals of clinical trials applications
For immediate consideration please click APPLY to begin the screening process with Alex.