Regulatory Affairs Cover Letter

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

In my previous role, I was responsible for regulatory expertise to teams on US and EU software and cyber security regulatory requirements within MMS.

Please consider my qualifications and experience:

• Proficiency in typical software, including MS-Word, MS-PowerPoint and Excel
• Maintains the Technical Files for CE market
• Represents the businesses with the Notified Body
• Prepares the global approbation plans for SW based medical device products
• Determines the standards and/or guidance applicable to SW based medical device products
• Supports the planning, preparing and execution of clinical investigations (when relevant)
• Successful track record of registering medical devices worldwide, in US, China, Japan, Canada, Brazil
• Strong understanding of Quality System Regulations requirements as they apply to the medical device industry

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

In my previous role, I was responsible for expertise and guidance in interpreting US, EU, and foreign governmental regulations, agency guidelines, and internal/corporate policies to ensure compliance is maintained and results are achieved.

Please consider my qualifications and experience:

• Knowledge of federal medical device regulations
• Experience with US FDA Regulations and European Medical Device Directives preferred
• Experience in worldwide regulatory systems is preferred
• Demonstrated expertise in medical device regulatory requirements and processes is preferred
• Demonstrated expertise in orthopaedics and orthopaedic device regulatory requirements is preferred
• Write and edit technical documents and product labels
• Strong experience working with common desktop applications such as MS Office
• Exposure to electronic document management systems (eDMS) and information management systems

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

In the previous role, I was responsible for guidance to organization on interpretation and impact to business; act as functional expert for EU MDR project team utilizing expert understanding of US and EU regulatory requirements (and subsequent guidance documents and implementing acts) and additional regulations worldwide.

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 with regulatory inspections and submissions
• Experience with data analysis, development of trends and measures, writing procedures, creating and presenting training courses
• Exposure to SharePoint & Microsoft Suite preferred
• Strong interpersonal communication skills, bilingual language skills extremely beneficial (I.e.-Spanish or Portuguese)
• Knowledge of both satellite and terrestrial FS networks and related regulatory regimes, including experience with interference modeling between terrestrial and satellite services involving statistical tools
• Excellent contacts and reputation with European regulators
• Fast and action-oriented
• Advanced level of verbal and written English

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

In my previous role, I was responsible for guidance to business unit on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, EU MDR (moving forward), ISO 13485, Canadian CMDCAS, US FDA’s and China CFDA’s guidance documents & etc.

Please consider my experience and qualifications for this position:

• Advise the Director of Quality Assurance FDA officials and investigators concerning company NADA (new animal drug application) records and procedures
• Review written responses to FDA inspection findings and provide the Director of Quality Assurance with recommendations that ensure FDA acceptance of company responses
• Work with the Manager of Administration in R&D in the development of regulatory affairs budgets and project schedules
• Approve department expenditures and ensure all administrative commitments are met
• Provide the department staff with coaching, training and career development opportunities to maximize the potential of each individual, build teamwork and problem solving skills and stimulate innovation in the workplace
• Ph.D., D.V.M., or M.S
• Should have a thorough knowledge of the pharmaceutical industry and regulated government regulations with extensive experience in dealing with consultants and clinical investigators
• Displayed experiences and career achievements to be assessed as capable in the competencies of Building Effective Teams, Driving Vision and Purpose, Attracting and Developing Talent, , Collaboration

I would like to submit my application for the regulatory affairs opening. Please accept this letter and the attached resume.

Previously, I was responsible for leadership, personnel development, training, coaching, and mentoring for staff especially regarding US and EU regulations.

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 collecting ifnormation from various sources, paper and electronic, and entering that information into computer systems
• Basic understanding of drug development and regulatory submission process
• Familiarity with Liquent InSite platforms, specificially InSight Manager
• Knowledge of Regulatory submissions types, agency review periods and requirements
• Support the Regulatory Manager and team on multiple projects with multiple internal stakeholders
• Provide information on global Regulatory projects by reviewing Regulatory guidance from multiple regulatory agencies
• Participate in and/or drive process efficiency enhancement projects where needed
• Ensure assigned projects are finalized and submitted in a timely manner