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Yyyyyy x. yyyyyy

1807 N Oak Park Ave. | Chicago, XXXXXX xxxxxx xxx-xxx-xxxx |


Profxxxxxxe of Qualifications

GMP (QSR) / CMDCAS / ISO | Management | Analytical | Registration | Listing/License Management | Training | FDA | ISO

medical devices pre- and post-market regulations | coaching | Communication | Teambuxxxxxxding | Customer Service

Product Release | Corrections & Removal Management| Strategic Planning | Internal/External Audits | Document Control

Capable, driven and team-focused Regulatory Compliance Professional with combination of strong educational background and demonstrated experience, leveraged to ensure compliance with both global government and local state agencies. Excel in prioritizing and managing workflows to increase productivity and align with pertinent deadlines. Compassionate, active listener with a personable leadership approach and drive to deliver support to others. Exude an impeccable work ethic, confirmed by colleagues at all levels as well as external business partners and performance auditors. Loyal and self-motivated, a change agent with an innovative approach to task completion. Seeking to transition into a role within the field that wxxxxxxl call on many years of experience with FDA, ISO and Health Canada regulations, as well as state licensing management expertise.


Professional Synopsis

ARJOHUNTLEIGH, INC. | Senior Regulatory Director 2010 2016

  Developing and maintaining Regulatory Affairs and Compliance systems and activities within North America regulations

  ensuring that the company and its products comply with current US, Canadian and European regulations.

  managed Quality Review Board (QRB) to assure timely approval and release of new products to the North American market

  working with international manufacturers and internal cross-functional colleagues to assure applicable 510(k) approvals, registrations/listings, design/technical history fxxxxxxes, labeling and training.

  Created database to accurately manage FDA facxxxxxxity establishments and product listings for 18 international manufacturing locations and 328 medical devices marketed in the United States.

  Created a field correction (recall) tool that improved efficiency, eliminated temporary staff and enabled faster closure.

  Led initiative to improve internal audit and non-conformance programs resulting timely and

  Developed metrics and dashboards for global executive management reporting, to identify opportunities for improvements


Quality/Regulatory Vice President 2009 2010

  Provided Regulatory and Quality Management leadership to the North American Region to ensure the Region met all regulatory compliance guidelines, policies and procedures.

  Provided advice, counsel and direction to senior managers and quality/regulatory team.


Vice President, Operations 2005 2009

  Provided leadership for Customer Service, Purchasing and Warehouse operations to

  ensure all areas complied with company quality standards


Earlier Roles


Manager, Quality/Regulatory, ARJOHUNTLEIGH, INC., 2001 2005

Regulatory Manager, Manan Medical Products, 1999 2001

Quality Compliance Supervisor, MPL Technologies, Inc. (DENTSPLY), 1995 1999


Education & Credentials


Bachelor of Arts, General Business, DePaul University

Certification, Medical Technician, Bryman Medical School

Certification, AdvaMed Training

Workshops and Certifications, FDA Learning

Member, Regulatory Affairs Professional Society(RAPS)


Community Involvement


Community mentor for at-risk young women, with a focus on self-development, empowerment and buxxxxxxding their self-esteem

Also organize food and clothing drives each year for homeless and single young mothers



Yyyyyy x. yyyyyy

1807 N Oak Park Ave. | Chicago, XXXXXX xxxxxx xxx-xxx-xxxx |



March 19, 2018



Hiring Agent Name


Company Name


City/State/Zip Code



Dear [Hiring Agent Name],


I am currently seeking a challenging career opportunity in a (INSERT TITLE OF TARGET POSITION) capacity and am submitting my resume for your review. In advance, thank you for your time and consideration. As demonstrated in the accompanying resume, my professional qualifications include the following accomplishments:


  I bring to any role years of demonstrated and progressive Regulatory Compliance acumen. I am skxxxxxxled in working under pressure to surpass both organizational and client expectations. My skxxxxxxl level and professionalism have been praised unanimously by colleagues, business partners and performance auditors.


  As a professional, I am highly comfortable in achieving greatness both as a cross-collaborative team member and an individual staff member. I interact well with independent and group stakeholders at all levels by carefully calling on my communication skxxxxxxls to foster positive working relationships.


  I possess a compassionate leadership style that is evidenced by the way I work with my colleagues. Among my related strong suits are my interpersonal capabxxxxxxities, abxxxxxxity to align with regulatory protocols, as well as my aptitude for managing projects effectively from start to end.


  Outside of my career background, I have a Bachelor of Arts in General Business from DePaul University. I am also certified as it pertains to my Medical Technician credentials, AdvaMed Training and FDA Learning. Furthermore, I am a current member of the Regulatory Affairs Professional Society (RAPS).


As an employee, you wxxxxxxl find me to be a driven team player committed to supporting you in achieving your objectives through superior performance. I am confident that I could be a valuable asset to your organization, and look forward to interviewing with you in the near future.



Yyyyyy x. yyyyyy

Enc. Resume













Yyyyyy x. yyyyyy

1807 N Oak Park Ave. | Chicago, XXXXXX xxxxxx xxx-xxx-xxxx |




March 19, 2018



Contact Name

Company Name


City/State/Zip Code



Dear _____________________:


I would like to thank you for providing me the opportunity to interview with you and discuss the exciting (TITLE OF POSITION APPLYING FOR) position currently avaxxxxxxable with your company. Having gained a deeper insight into the job requirements and your objectives, I am confident you wxxxxxxl find me a valuable asset in achieving your goals.


As discussed, my background should translate to dynamic results as a member of your team. In particular, I believe you wxxxxxxl find my expertise in (ADDRESS A FEW SKXXXXXXLS/QUALIFICATIONS/ACHIEVEMENTS RELEVANT TO THE POSITION WHICH YOU DISCUSSED DURING THE INTERVEIW) vital to your immediate and long-term objectives.


Should you have any additional questions, or to further discuss this opportunity, please feel free to contact me at your earliest convenience. Again, thank you for the enlightening interview. I look forward to your response and am eager to contribute to your success.



Yyyyyy x. yyyyyy


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