Quality Assurance Mechanical Engineering

YUNUS GULMEZ PHONE 857-***-****

*********@*******.***

*** ***** ******. *** : 2 Boston 02130 MA

C AREER SUMMARY

*Developed Quality Assurance and Regulatory Affairs processes, to ensure regulatory compliance

with domestic and global requirements.

*Thorough understanding of regulatory requirements for the development devices, for FDA, EU.

*Create, review, and update Technical Files, Declaration of Conformity, and Essential Requirement

Checklist for products to be distributed in the EU

*Maintain current regulatory knowledge of domestic and international regulations, guidelines, and

standards; including: ISO 13485 and 21 CFR Part 820, MDD/IVDD requirements

*Support the submittal of product regulatory filings and maintenance with focus on US 510(k),

PMA, and CE Mark.

*Fluency in English, Italian, Turkish and conversational Spanish.

*Available to relocate nation wide.

E DUCATION

Regis College, Weston, MA May, 2014

Master of Science, Regulatory Affairs and Clinical Research Management.

Concentration in Regulatory Affairs Management

University of Sassari, Sassari, Italy 2008-2009

Bachelor of Science, Pharmacy

Exchange Program: Nine courses were taken in Italian language

Hacettepe University, Ankara, Turkey 2011

Bachelor of Science, Pharmacy

P ROFESSIONAL EXPERIE NCE

Respiratory Motion Inc., Boston, MA September 2013- Present

Regulatory Affairs Assistant

• Prepare international documentations to support product registration globally

• Execute and maintain of calibration records

• Create templates and other documentation for other QS support as needed.

• Create, review, and update Technical Files, Declaration of Conformity, and Essential

Requirement Checklist for products to be distributed in the EU

• Perform Regulatory Assessment for Change Controls

• Evaluate proposed changes to product design or manufacturing processes and assess regulatory

impact of the proposed changes with regard to worldwide approvals

Peace Island Institute, Boston, MA February 2012-January 2013

Organizer

Turkish – American association, which develops original perspectives on global and social issues.

• Coordinator seminars, panels, and meetings with speakers and attendees.

• Organized six luncheons with Boston Representatives, and awards dinner attended by

approximately 200 people.

University of ROME3, Rome, Italy September-November, 2011 Italy

Researcher

Department of Mechanical Engineering

Collaborated with group of international research students

•

Conducted experiments in chemical laboratory to examine antioxidant activity hydroxytyrosol

•

derivatives

Analyzed and reported results under Prof. Gambagorta

•

Knidos, Ankara, Turkey January 2011-July 2011

Data Entrist

Knidos is contracted by banks to prepare financial and life history profiles on American clients who are

under foreclosure

• Collaborated with American Government databases to develop financial history profiles on

clients

• Trained to professionally handle personal confidential information on clients such as land

registries, marital history, and financial loan history

TC Health, Ankara, Turkey September 2010 – June 2011

Pharmacist

Software database provider for all Turkish Military and pharmacies

• Populated pharmaceutical database with drug descriptions & usage instructions, and financial

reimbursement details

Abdi Ibrahim, Istanbul, Turkey June-August 2010

Intern

Largest pharmaceuticals manufacturer in Turkey. Highest endorsement range amongst foreign and

domestic companies

• Learned protocols and procedures for solid production facility regarding inspection

• Applied GMP (Good Manufacturing Practices) to incoming ingredients, and followed production

processes

Menarini Group, Florence, Italy June-August 2009

Intern

Global pharmaceutical manufacturer and supplier

• Industrial rotation to learn production, quality, and regulation between laboratories and

departments of the factory

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