Senior Regulatory Affairs Cover Letter

Senior Regulatory Affairs Cover Letter

4.5
187 votes for Senior Regulatory Affairs

15 Senior Regulatory Affairs cover letter templates

What to include in a Cover Letter
1
Company Address
2
Salutation
3
Compelling Details
4
Respectful Closing

How to Write the Senior Regulatory Affairs Cover Letter

40445 Renner Points
Goldnerbury, MA 86548-4117
Dear Charlie Rippin,

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

In my previous role, I was responsible for feedback and approve design and manufacturing changes, nonconforming materials reports, test protocols and reports to ensure regulatory compliance with FDA, Health Canada, Medical Device Directive (MDD), ISO 13485 and applicable standards and determine filing or notification 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 with software products preferred
  • Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards
  • Excellent track record for product clearances worldwide
  • Experienced in cGMP and other regulatory compliance requirements
  • A “hands-on” individual who enjoys challenge, is capable and dedicated to getting the job done
  • A mature thinking and acting executive with good common sense and judgment, and a broad business perspective with outstanding administrative capabilities to build, motivate and manage a strong quality organization
  • Experience writing 510(k)’s is preferred
  • Experience with EU technical files is preferred

Thank you in advance for reviewing my candidacy for this position.

Sincerely,

Emerson Farrell

Responsibilities for Senior Regulatory Affairs Cover Letter

Senior regulatory affairs responsible for support for external and Internal audits.Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO 13485, previous MDD, MDR, etc.).

Working knowledge of 21 CFR 820 -Quality System Regulation, and ISO 13485 and 9001
Experience presenting at FDA meetings is preferred
Exceptionally strong team leader and team player with excellent communication skills, coaching, project management, problem-solving, risk management, and presentation skills
Experience and knowledge in preparation of essential regulatory documentation including Pre-Submissions briefing packages, 510(k) submissions, PMAs, Health Canada device license applications, CE-IVD technical files
Substantial regulatory experience within a regulatory compliance function and with a pharma background would be key and ideally within wound care would be a nice to have here due to the product portfolio
Collaboration and team playing skills is key here being able to take ownership for projects and tasks be accountable for their own work
Have a current working knowledge of individual country legislation relevant to similar firms to Smith and Nephew and in particular in the Wound Management products side of things would be ideal
Excellent English knowledge in writing and speaking

Senior Regulatory Affairs Examples

Example #1

Example of Senior Regulatory Affairs Cover Letter

8003 Stamm Passage
Jeanchester, WA 15958-0778
Dear Sutton Greenholt,

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

Thank you for your time and consideration.

Sincerely,

Emerson Olson

Example #2

Example of Senior Regulatory Affairs Cover Letter

9691 Kassulke Squares
Derekchester, AL 77913-8334
Dear Robin Jerde,

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

Thank you for your time and consideration.

Sincerely,

Robin Roberts

Example #3

Example of Senior Regulatory Affairs Cover Letter

8547 Larkin Grove
Venettatown, MD 35689-0394
Dear Peyton Considine,

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 really appreciate you taking the time to review my application for the position of senior regulatory affairs.

Sincerely,

Drew Kertzmann

Example #4

Example of Senior Regulatory Affairs Cover Letter

582 Veum Parks
Kundeborough, ME 83490
Dear Emery Bashirian,

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

Thank you in advance for reviewing my candidacy for this position.

Sincerely,

Sutton Pollich

Example #5

Example of Senior Regulatory Affairs Cover Letter

86460 Simonis Harbors
East Parthenia, MD 54253-8222
Dear Phoenix Batz,

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

Thank you in advance for reviewing my candidacy for this position.

Sincerely,

Drew Gleason

Resume Builder

Create a Resume in Minutes with Professional Resume Templates