Regulatory Affairs Specialist Cover Letter

Please consider me for the regulatory affairs specialist opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for guidance on global compliance, such as CE Marking and product registrations, clinical evaluations, Canada Medical Device Regulations, etc.

Please consider my qualifications and experience:

• History of successful 510(k)/IDE/PMA device/combination product submissions and other worldwide submissions and clearances
• Previous experience supporting manufacturing and design changes
• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Previous experience with document management systems and change control systems
• Negotiate internally
• Has a sound knowledge of a variety of alternatives and their impact on the business
• Apply business and regulatory ethical standards
• Good working knowledge of various FDA submission types and forms for drugs/biologics

I am excited to be applying for the position of regulatory affairs specialist. Please accept this letter and the attached resume as my interest in this position.

In my previous role, I was responsible for strategic regulatory input and prepare content for regulatory strategic documentation, eg response to FDA information requests.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Reviews clinical protocols to assure collection of appropriate data for regulatory submissions
• Periodically monitors status of clinical studies and reviews analysis of resultant clinical study data
• Provides regulatory opinions on premarket regulatory requirements, export, and labeling requirements
• Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP) and Quality System Regulations (QSR)
• Working knowledge of business intelligence applications (e.g., Business Objects), SQL, SSRS
• Process improvement mindset or experience
• Conduct or assist in conducting economic evaluations using various costing models
• Experience in developing costing, economic or statistical models Detailed knowledge of incremental costing and economic principles related to costing, including concepts of time value of money, and economic evaluators such as Net Present Value (NPV), payback period, rate of return, cost of capital

I submit this application to express my sincere interest in the regulatory affairs specialist position.

In my previous role, I was responsible for information and materials for Certificate to Foreign Governments (CFG), and medical device listings for FDA.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Good working knowledge of clinical protocols and familiarity with clinical study design
• Prior experience with entering clinical trial information with ClinTrials.gov database is preferred including experience interpreting/retrieving clinical study results from final study reports for entry into the database
• Knowledge of relevant regulatory legislation
• Experience with injectable products labeling requirements and familiarity with eCTD viewers such as eCTD Express (CSC), ViewPoint (Accenture) and ISI ToolBox/Publisher is a pus
• Strong working knowledge of FDA, ICH and EU guidelines related to regulatory topics
• Strengths in strict attention to detail and accuracy
• Handling varied high-priority tasks for multiple projects simultaneously
• Reliably complete projects within time constraints

I submit this application to express my sincere interest in the regulatory affairs specialist position.

In my previous role, I was responsible for guidance and counsel to staff and global manufacturing facilities regarding compliance with FDA Quality system and GMP requirements, as well as international and national standards, when necessary.

My experience is an excellent fit for the list of requirements in this job:

• Assist in the review of advertising and promotional items
• Understands and interprets U.S. and international medical device and in vitro diagnostic device (IVD) regulatory requirements
• Provides guidance on requirements to product development teams
• Develops strategies for submissions to FDA and other regulatory agencies
• Provides risk assessments and regulatory options
• Interacts and negotiates with U.S. regulatory agencies
• Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests
• Participates in the development and review of product release documents

I am excited to be applying for the position of regulatory affairs specialist. Please accept this letter and the attached resume as my interest in this position.

In my previous role, I was responsible for regulatory approval and counsel for post-market surveillance medical device reporting FDA and Health Canada requirements.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Experience using Big Data tools such as SAP HANA, Hadoop, Netezza
• Proficiency in Tableau data visualization
• Exposure to statistical analysis concepts and tools such as SAS and R
• Lead requirement solicitation sessions with end customer and partner with customer to drive best solutions
• Knowledge of Pharmaceutical Affairs Law and Regulations
• Effective written and verbal communication with internal and external stakeholders in Korean and English
• High understanding of regulatroy compliance activity
• Preferred with whom has high learning agility of new regulatory areas