Regulatory Affairs Specialist (Concentric)Responsible for the coordination and preparation of document packages for regulatory submissions in one or more of the following geographic regions: United States, Europe, Japan, Canada, and Intercontinental.
Specific Duties and Responsibilities
•Assists in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: Shonin, Design Dossier, Technical File. Ensures that existing approvals and documentation are maintained, including Foreign Trade Status. Communicates with in-country RA personnel to facilitate global clearances/approvals.
•Develops regulatory strategies for project teams. Provides input on and reviews protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, and clinical studies. Monitors, researches and obtains information [FDA/EU Guidance and MDD publications] on approvals of competitors, and proactively shares this information with interested parties.*
•Communicates with regulatory agencies
•Evaluates proposed changes to products and controlled documents; recommends and implements global regulatory action plans based on the changes. Organizes and maintains RA files.
•Reviews labeling (Instructions for Use, labels, promotional materials) for compliance to: standards, guidelines, regulations, and regulatory approvals/clearances.
•Assists in performing basic to moderately complex research to support strategic planning.
•May Mentor others on an infrequent basis.
•Provides regulatory support to other Stryker Neurovascular Personnel to facilitate cross-divisional leverage.
• Analyzes existing systems and procedures, recommends solutions/improvements, and writes Work Instructions and SOPs, as needed to support departmental functions and Quality System.
•Understands: systems, biocompatibility requirements, Design Control, Medical Device Directive, Essential Requirements, labeling requirements, Quality System Regulation, export requirements, and regulatory requirements of pertinent regions. Monitors changes in the regulatory environment, evaluates impact, and communicates to interested parties.
•Uses existing project management tools.
•Performs responsibilities required by the Quality System and other duties as assigned or requested.
Qualifications/Work Experience
•2 - 4 years Regulatory Affairs experience, medical industry experience preferred.
•Working knowledge of FDA & EU regulations with prior submission experience.
•General understanding of product development process and design control.
•General understanding of regulations applicable to the conduct of clinical trials.
•Ability to manage several projects.
•Proficiency with Microsoft Office.
•Effective research and analytical skills.
•Effective written and oral communication in English, technical writing and editing skills. Ability to work independently with minimal supervision.
Education and/or Special Training
•Bachelor's degree
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