Regulatory Lead

• Feb 2022 - Present

• Serve as regulatory affairs lead on new product development projects (AI Maternity device) guiding teams on clinical trial start-up, product development requirements for health authority approvals, and design changes to on market products. • Provided expert regulatory guidance and provided rationale to cross-functional teams on validation requirements needed to support submissions as well as review protocols/reports and ensure compliance with regulations. • Serve as regulatory affairs lead on new product development projects (AI Maternity device) guiding teams on clinical trial start-up, product development requirements for health authority approvals, and design changes to on market products. • Provided expert regulatory guidance and provided rationale to cross-functional teams on validation requirements needed to support submissions as well as review protocols/reports and ensure compliance with regulations.

International Business Development Manager

• May 2020 - Sep 2021

• Responsible for identifying new business opportunities and developing and sustaining new and existing markets.• Market evaluation and competitive analysis. Set-up of strategies and actions for new markets business development (partner research, partner profiling, screening, and contact) in Middle East, China and Malaysia. • Responsible for identifying new business opportunities and developing and sustaining new and existing markets.• Market evaluation and competitive analysis. Set-up of strategies and actions for new markets business development (partner research, partner profiling, screening, and contact) in Middle East, China and Malaysia.

Regulatory Affairs and Business Development Consultant

• Oct 2012 - Dec 2020

• Counseled on regulatory strategies for medical device product registration, technical dossiers, tender submissions, market access and import procedures (cut import costs by 20%).• Collaborated with internal stakeholders to ensure alignment of regulatory strategy with business priorities, objectives, and deadlines. • Led business negotiations with international suppliers and local customers. • Counseled on regulatory strategies for medical device product registration, technical dossiers, tender submissions, market access and import procedures (cut import costs by 20%).• Collaborated with internal stakeholders to ensure alignment of regulatory strategy with business priorities, objectives, and deadlines. • Led business negotiations with international suppliers and local customers.

Factory Manager

• Apr 2018 - Oct 2019

• Oversaw all factory activities and processes to ensure product quality and performance, and safety of 130 people.• Increased production by %200 in one year (without increasing manpower), through implementing initiative operational procedures.• Resolved daily challenges enabling smooth flow activities. • Oversaw all factory activities and processes to ensure product quality and performance, and safety of 130 people.• Increased production by %200 in one year (without increasing manpower), through implementing initiative operational procedures.• Resolved daily challenges enabling smooth flow activities.

International Commercial Director

• May 2014 - Apr 2018

• Managed and supported all procedures regarding sourcing international partners, price and payment negotiations, purchase conditions, inspections, shipments and transits and custom formalities. • Managed and supported all procedures regarding sourcing international partners, price and payment negotiations, purchase conditions, inspections, shipments and transits and custom formalities.

Regulatory Affairs and Business Development Manager

• Feb 2009 - Apr 2018

• Started business collaborations with two major international partners, resulting in revenue growth of %500 in 5 years.• Established market leadership and achieved 2nd position for one product in Iran market against major Chinese competitors and locally manufactured products. • Started business collaborations with two major international partners, resulting in revenue growth of %500 in 5 years.• Established market leadership and achieved 2nd position for one product in Iran market against major Chinese competitors and locally manufactured products.

Procurement Manager

• Sep 2011 - Sep 2013

• Invited qualified companies to bid in tenders, concluded agreements, acquired necessary contractual documents, settled discounts to satisfy cost break-down schedule of project.• Concluded agreements, expedited material delivery and material shortages, acquired client satisfaction and approval on received material. • Invited qualified companies to bid in tenders, concluded agreements, acquired necessary contractual documents, settled discounts to satisfy cost break-down schedule of project.• Concluded agreements, expedited material delivery and material shortages, acquired client satisfaction and approval on received material.

Commercial Director

• Mar 2008 - Sep 2012

Private medical equipment company active in import and distribution disposable OR products. Private medical equipment company active in import and distribution disposable OR products.

Technical Manager

• Nov 2008 - Mar 2010

Multi-national medical equipment trading company, With headquarters in Turkey and Branches in Sweden and Iran; In the field electrophysiology equipment and patient transfer aids. Multi-national medical equipment trading company, With headquarters in Turkey and Branches in Sweden and Iran; In the field electrophysiology equipment and patient transfer aids.

Commercial Assistant

• Feb 2008 - Feb 2009

• Obtained sample products, placed orders, and organized shipments, checked shipping documents.• Searched for new suppliers and discussed conditions according to local market. • Obtained sample products, placed orders, and organized shipments, checked shipping documents.• Searched for new suppliers and discussed conditions according to local market.

Commercial Assistant

• Aug 2006 - Apr 2008

Private medical equipment company active in import and distribution of home-use and laboratory rapid tests. Private medical equipment company active in import and distribution of home-use and laboratory rapid tests.

Sales And Marketing Specialist

• Feb 2007 - Feb 2008

Private medical equipment company active in production of first aid bandages and distribution of medical disposables. Private medical equipment company active in production of first aid bandages and distribution of medical disposables.

Financial accounting Programmer

• Aug 2006 - Mar 2007

Large Private Educational and Cultural institute. Large Private Educational and Cultural institute.

CE Standard Specialist

• Jan 2006 - Aug 2006

Private medical equipment company active in import and distribution of lithotripsy devices and also manufacturer of surgical training dummies. This company was also the partner of a CE Notify Body in Iran. Private medical equipment company active in import and distribution of lithotripsy devices and also manufacturer of surgical training dummies. This company was also the partner of a CE Notify Body in Iran.

Professional Translator

• Aug 2003 - Jan 2006