HAZAR BAASIRI
SENIOR REGULATORY AFFAIRS CONSULTANT
Madrid
Summary
Senior regulatory affairs professional with 12 years’ experience, specialized in medical devices. Expert in registrations, variations, strategy, post market surveillance and compliance to MDD / MDR, with special focus on international markets (MENA / Africa) and knowledge of other regions (LATAM / APAC). Manager of a small team. Fluent English and Arabic, B2 Spanish. Right to work in Spain. Available immediately.
Overview
12
12
years of professional experience
6
6
years of post-secondary education
2
2
Certifications
3
3
Languages
Work History
SENIOR REGULATORY AFFAIRS CONSULTANT
Convatec
Dubai
01.2021 - 01.2024
- Company Overview: International team, based in Dubai.
- Three years in the medical device regulated industry, following EU MDD / MDR & PMS, class I - II - III.
- Drove international registrations & variations to achieve 95% market import coverage and avoid stop ship.
- Crafted documents, technical files, for MDD - MDR transition of top 5 products in class II - III.
- Coached a small team of 3 persons and supported them in registration processes.
- Decreased approval time for region by 30% from 1.5 year to 1 year, by negotiating with health ministries and opening communication channels to be more visible and approachable.
- Executed overall regulatory strategy for current and pipeline products to ensure proper planning.
- Actively managed PMS, post market surveillance: complaints, FSN, FSCA, CAPA.
- Built regulatory intelligence database that clarified documental and time requirements to sales team and management, improving efficiency and avoiding repetitive email inquiries by ~ 40 %.
- Supervised Internal Audit and conformed to ISO 13485.
- Advised other regions during staffing shortages (LATAM, APAC, Australia).
- Experience with Track wise and SharePoint.
REGULATORY CONSULTANT
IQVIA
Dubai
01.2018 - 08.2018
- Eight months as management consultant @ IQVIA.
- Educated +20 clients on the impact of EU MDR 245/2017 on market access.
- Executed, with a team, gap analysis and roadmaps for 8 projects.
- Crafted presentations and documentation on updated regulations that were used by principals in high profile meetings.
- Spearheaded 6 due diligence requests by major pharmaceutical /medical corporations.
- Checked labeling and package inserts for clients.
REGIONAL REGULATORY & SALES MANAGER
Natera
Istanbul
12.2015 - 01.2018
- Company Overview: Turkey/MENA-Grew and developed business of NIPT in MENA for California-based genetics biotech.
- Tripled revenue in UAE from $14,000 to $40,000/month over 10-month period; 35 to 99 genetic tests; test value of 400$ out of pocket.
- More than doubled sales in Tunisia from 20 to 50 patient samples/month in 3 months, equivalent to $8,000 to $20,000 / month, out of pocket.
- Successfully managed technology transfer deal for Dubai.
- Handled IVD registration in region prior to commercialization.
- Promoted and introduced new concept of NIPT through conferences, dinners, doctor seminars and conversation.
- Negotiated contracts with our partners, ensuring adequate pricing and terms for company profitability.
REGULATORY AFFAIRS SPECIALIST
Boston Scientific
Beirut
12.2011 - 08.2014
- Company Overview: Global company.
- Focus on regulatory processes in the MENA region, record of top achievement in registration.
- Registered 5x more products in Egypt in 1st year joining vs prior, via lean process, efficient model.
- Cut the approval timing by 1/2 through country specific templates & streamlining (from 1.5 yrs to 8 months.)
- Secured 3–5 year approvals for 90% of products in market within 3 years of handling overall-100 products in 5 units, via country specific templates, follow up and lobbying.
- Ensured respect for the quality system QMS for the department, minimizing audit findings (3 minor nonconformities, 0 major, over 2 audits.)
- Handled post-market surveillance activities, identifying trends and any potential safety concerns.
HEALTH ANALYST
NCQA
Washington DC
03.2008 - 06.2011
- Company Overview: Quality in healthcare, Washington DC, USA.
- Three years’ experience in data analysis /performance indicators at NCQA.
- Analyzed KPI and benchmarking data of health plans in the USA.
- Extracted and analyzed survey information of medical patients as related to their experience.
- Successfully prepared all analyses for State of Healthcare 2008, a major report on the development of healthcare service delivery in the USA.
- Programmed in SAS code to perform analysis.
- Handled big governmental clients (CDC, NIH.)
- Co-published for Center for Disease Control publication featured in Journal for America Medical Association 2009 (JAMA).
Education
Master of Public Health -
COLUMBIA UNIVERISTY IN THE CITY OF NEW YORK
New York, USA 08.2006 - 01.2008
BSc - Biology
AMERICAN UNIVERSITY OF BEIRUT
Beirut, Lebanon 09.2002 - 06.2006
Skills
Medical Device Regulations
Certification
EU MDR Green Belt, Easy Medical Device, 10/01/22
Timeline
SENIOR REGULATORY AFFAIRS CONSULTANT
Convatec
01.2021 - 01.2024
REGULATORY CONSULTANT
IQVIA
01.2018 - 08.2018
REGIONAL REGULATORY & SALES MANAGER
Natera
12.2015 - 01.2018
REGULATORY AFFAIRS SPECIALIST
Boston Scientific
12.2011 - 08.2014
HEALTH ANALYST
NCQA
03.2008 - 06.2011
Master of Public Health -
COLUMBIA UNIVERISTY IN THE CITY OF NEW YORK
08.2006 - 01.2008
BSc - Biology
AMERICAN UNIVERSITY OF BEIRUT
09.2002 - 06.2006
EU MDR Green Belt, Easy Medical Device, 10/01/22
Saudi FDA (SFDA) Registration, 03/01/14
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