Erna Dizdarević Šehović
Praha
Summary
Experienced regulatory affairs specialist with over 15 years in the medical device sector, currently at Edwards Lifesciences. Skilled in EU regulatory compliance, international registration processes, and cross-functional collaboration. Proven track record in developing regulatory systems, evaluating documentation, and supporting product lifecycle management. Strong communicator with experience in public speaking, self and team leadership, and preparing submissions of regulatory documentation across EMEA and LATAM regions.
Overview
20
20
years of professional experience
Work History
Senior Regulatory Affairs Specialist
Edwards Lifesciences
09.2021 - Current
- Supporting international registration processes of medical devices in EMEACLA region
- Knowledge management - playbooks/Country requirements matrix
- Promotional Material-Marketing & Launch Support, Claims & Materials Review
- Supporting operations at the EU warehouse
HEAD OF DEPARTMENT FOR MEDICAL DEVICES
AGENCY FOR MEDICINES AND MEDICAL DEVICES OF MONTENEGROCALIMS
01.2009 - 08.2018
- Notification of medical devices
- Harmonizing legislation in medical devices with requirements and standards set in EU legislative
- Member of national team of accession of Montenegro in to EU for two chapters: Chapter 1: Free Movement of Goods and Chapter 7: Intellectual property law
- National focal point for Health Technologies (World Health Organization) from 2010-2016
- Evaluating adverse incidents related to medical devices
- Attendance of meetings of CAMD -Competent Authorities for Medical Devices
- Continual education in fields of registration of medical devices, vigilance and surveillance of medical devices.
REGULATORY AFFAIRS OFFICER FOR MEDICAL DEVICES
ADMINISTRATION FOR MEDICINES AND MEDICAL DEVICES OF MONTENEGRO
11.2007 - 01.2009
- Developing process of notification medical devices.
DENTAL PRACTITIONER
HEALTH CARE CENTER OF PODGORICA
01.2006 - 01.2007
- Diagnosing and treating diseases of teeth and oral tissues.
Education
SPECIALIST IN ORTHODONTIC -
Faculty of Dentistry with Clinics, University of Sarajevo
01.2014
DR -
Faculty of Dental Medicine, University of Belgrade
01.2005
Skills
- Organizing and heading department of medical devices
- Problem solving orientate, multitasking and flexibility
- Detail orientation and accuracy
- Regulatory submissions
- Audits
- International regulations
- Organizational skills
- Effective communication
Driving Licence
B
Personal Information
- Date of Birth: 08/08/79
- Gender: Female
- Nationality: Montenegrin
Communication Skills
- Listening and effective speaking
- Excellent communication skills ranging from one on one patient-doctor (gained while working as a Doctor of Dentistry), public presentation for small and large audience, to direct negotiation with representatives of European Commission.
- Good interpersonal relationship skills gained through active participation in workshops and also working for 10 years with same team.
Hobbies and Interests
- Traveling
- Photography
- Dance
- International cuisine
Training
- An Introduction to the Medical Device Regulation, Management Forum, 11/20/08, London, UK
- International Conference on Harmonization with the EU Medical Devices Legislation, 05/14/08 - 05/15/08, Trogir, Croatia
- EU Communication Skills in English, British Council, 10/2008, Podgorica, Montenegro
- Skill for EU, British Council, 05/05/09, Sarajevo, Bosnia and Herzegovina
- First Global Forum on Health Technologies, 09/09/10 - 11/09/10, Bangkok, Thailand
- Second Global Forum on Health Technologies, 11/22/13 - 11/24/13, Geneva, Switzerland
- Regulatory seminar and workshop of vigilance of medical devices, 2015, Sarajevo, Bosnia and Herzegovina
- Advertising and promotional claims for medical device in EU, April 2025
Timeline
Senior Regulatory Affairs Specialist
Edwards Lifesciences
09.2021 - Current
HEAD OF DEPARTMENT FOR MEDICAL DEVICES
AGENCY FOR MEDICINES AND MEDICAL DEVICES OF MONTENEGROCALIMS
01.2009 - 08.2018
REGULATORY AFFAIRS OFFICER FOR MEDICAL DEVICES
ADMINISTRATION FOR MEDICINES AND MEDICAL DEVICES OF MONTENEGRO
11.2007 - 01.2009
DENTAL PRACTITIONER
HEALTH CARE CENTER OF PODGORICA
01.2006 - 01.2007
DR -
Faculty of Dental Medicine, University of Belgrade
SPECIALIST IN ORTHODONTIC -
Faculty of Dentistry with Clinics, University of Sarajevo
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