Compliance Staff Cover Letter

I submit this application to express my sincere interest in the compliance staff position.

Previously, I was responsible for assistance to both internal and external auditors during quarterly reviews, annual audits and Sarbanes Oxley testing.

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:

• Field action execution for the PAS business, including but not limited to participation at Situation Analysis meetings, documenting regulatory rationales for “no action taken”, agency reporting, customer letter development, communication with all regions, coordination with 3rd party recall contractor, responding to customer questions on field actions and monitoring of trends
• Input to PAS Management Review
• Monitoring Adverse Event reporting the processes and procedures
• Acts as an official correspondent with FDA and notified bodies on all related matters
• Supports Quality Systems with Regulatory inspections
• Facilitates documentation of segment or corporate audit program for PAS sites
• Works in coordination with Regulatory Affairs to maintain establishment registrations for all PAS facilities
• Supports implementation and maintenance of PAS Unique Device Identification (UDI)

I submit this application to express my sincere interest in the compliance staff position.

Previously, I was responsible for input and recommendations to incorporate / improve design of controls within regulatory risk requirements and framework.

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:

• Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills
• Strong understanding of pharmaceutical and/or medical device supply chain
• Knowledge of GxP’s, FDA guidelines, and other relevant international and domestic relations
• Experience qualifying cold-chain shipping containers
• Proven success in project management in the pharmaceutical or medical device industry
• Role model for Beckman Coulter values
• Previous consulting experience, including hazardous site assessment experience, such as Phase I, Phase II, and remediation is preferred
• Knowledge of medical device regulations such as FDA (21CFR 820), EU, … and related IEC/ISO standards such as ISO 13485, IEC 60601-1, ISO 14971

In response to your job posting for compliance staff, I am including this letter and my resume for your review.

In the previous role, I was responsible for support and oversight to Company’s various IT audit projects and testing initiatives, including audits of its internal controls.

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:

• Certifications in Regulatory Affairs/Compliance desirable
• Demonstrated familiarity with databases and other tools used to manage compliance policies and procedures
• Working knowledge of instructional design “e-Learning,” virtual and instructor-led course delivery
• Understanding of Learning Management Systems (LMS) and compliance reporting requirements
• Able to quickly establish credibility with stakeholders
• Adaptable, dependable and committed to professional excellence
• Effectively communicate complex regulatory requirements to management in an appropriate level of detail
• Proficiency in full suite of Microsoft Office applications

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

Previously, I was responsible for enterprise-wide oversight of the internal and external audit process including: risk assessment, external audit management, preparation and facilitation.

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

• Experience in documenting policies and procedures, system issues, and in drafting guidelines and training materials
• Experience communicating with technical and operations teams
• Demonstrate commitment to compliance with applicable laws and regulations, the Company’s Ethics and Compliance Code of Conduct and other Company policies and procedures
• Passion to work for a company that values leadership, empowerment, flexibility, and an entrepreneurial spirit
• Bachelors in engineering, Environmental or H&S Science, Occupational H&S, Health Sciences, or related discipline
• GSP or ASP certification preferred
• Familiarity with OSHA, EPA, and state regulations
• Quality related certifications (RAC certification, ASQ - CQA, CQE or SCQE, ISO Lead Assessor) are preferred

I submit this application to express my sincere interest in the compliance staff position.

In my previous role, I was responsible for recommendations to program policies and systems as needed to ensure compliance with Sarbanes-Oxley and internal and external audit findings.

Please consider my experience and qualifications for this position:

• Plan, coordinate, and conduct quality system audits of J&J Vision facilities and supportive activities for compliance as mandated by federal and international regulations and standards (e.g., FDA QSR, FDA cGMP, ISO, GCP) and Company requirements
• Providing support for FDA, Health Authority and Notified Body inspections conducted at J&J Vision locations, including readiness activities, front- and back-room participation/management and general inspection support as requested
• Develop and maintain key quality and compliance performance metrics
• Promote a culture of compliance to regulations, standards, and procedures and risk management throughout the organization
• Experience in cross-functional projects/initiatives
• Verbal and written communication skill in Japanese and English
• Computer skill with MS-Office applications (Word, Excel, and PowerPoint)
• Sufficient knowledge of global/local regulations such as J-PMD Act, cGMP, GQP, GDP