Senior Regulatory Affairs Cover Letter

In response to your job posting for senior regulatory affairs, I am including this letter and my resume for your review.

Previously, I was responsible for input as requested for device design and process verification and validation activities, review and collate documentation required for 510(k) and medical device/pharmaceutical combination product FDA submissions.

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:

• Subject-matter expertise regarding various regulations surrounding the Global Consumer Banking (GCB) business such as Fair Credit Reporting Act (FCRA), Flood Disaster Protection Act (FDPA), Truth in Lending Act (TILA), Equal Credit Opportunity Act (ECOA), Regulation AA, and Fair Housing Act
• Relevant expertise of Financial Services Compliance and Global Consumer Banking programs, consumer protection regulations, standards, risks and typologies
• Exceptional analytical, negotiation, and problem solving skills
• CPA, ACA, CFA, CIA, CISA or similar ceritfication
• Fluency (oral and written) in both Chinese and English
• Be patient and earnest on product registration projects
• Understanding of the US regulatory framework for medical devices
• Experience with Class I, II, sterile, and combination medical devices

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

Previously, I was responsible for leadership and coordinate presentation of information by cross-functional Invacare associates during audits including FDA inspections and ISO audits.

Please consider my qualifications and experience:

• Follow up of developments and changes in the local & global regulations and analyzing the potential impact on the registrations
• Interaction with Agency members and external stakeholders
• Lead GMP related tasks including inspections which require close follow up with internal and external stakeholders
• Act as a key role at brand teams (contains multiple functions) to provide regulatory input/advice
• Ensure timely regulatory submissions and approvals of new Marketing Authorisation applications & GMP dossiers
• Lead strong relationships with internal and external stakeholders
• Ensure the organization’s regulatory activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards
• Knowledge of domestic and international medical device standards and regulations

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

Previously, I was responsible for review, consultation and support for regulatory agency (UL, CSA, TUV, Notified Bodies, FDA, ISO registrars, etc) communications for EPM.

Please consider my experience and qualifications for this position:

• Familiarity with Class III, cosmetic or OTC products desirable
• Drafted and submitted three documents into the US FDA or similar US Governmental Agency
• Authored and implemented a minimum of 3 standard operating procedures
• Experience in UDI US requirements
• Executed or managed a post market action in the US
• Experience with FDA electronic submission id preferred
• Experience with US submissions, 510(k), IDE, PMA, would be helpful
• International Regulatory Affairs experience is desirable

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

Previously, I was responsible for consultancy on human factors and provide consultancy on standards on usability as required by medical device regulations legislated by applicable governing bodies, such as US FDA, EU MDR, Health Canada, Australia TGA.

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:

• Very good knowledge of Polish and EU regulations regarding cosmetics
• Good understanding of cosmetics & commodities regulatory and market requirements
• Medical devices & medicines OTC – will be additional advantage
• Good understanding of advertising law for cosmetics and commodities
• Understanding of drug development process, clinical trial phases
• Have a good command of written and spoken English
• Work precisely according to procedures, rules and regulations
• Planning and execution of post-approval submissions (renewals, technical variations, new indication, label updates) and conduct effective cross-functional interactions to preserve business continuity

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

Previously, I was responsible for broad technical expertise in OSHA, FDA, ISO 10993, and other global substance control regulations.

Please consider my experience and qualifications for this position:

• Knowledge of domestic and international labeling requirements
• Substantial regulatory experience within a regulatory compliance function and with a medical devices background would be ideal and within wound care would be a nice to have here due to the product portfolio
• Experience in a similar role within a regulated industry
• Experience in invitro diagnostics would be of a great advantage
• Working knowledge of the European and other International regulations
• Experience in working with SAP, (experience with Trackwise preferred)
• Familiarity with FDA and international regulations for IVDs and/or medical devices
• Direct experience working with 21 CFR 820 and ISO 13485