Senior Regulatory Affairs Specialist
Gulf Medical company
Total des années d'expérience :7 years, 9 Mois
Designation Chronology:
• October 2018 - Present: Regulatory Affairs Specialist
• March 2018 - January 2019: Product Specialist / Gynecologist Product Specialist.
Accomplishments:
• Ownership for maintaining regulatory compliance via registrations, document control, being part of the internal and external audit team, analyzing registration data, and streamlining registration activities.
• One of the two main point of contact for SFDA. Nurtured synergistic relationships between Gulf Medical and the Saudi Food & Drug Authority SFDA.
• Earned a track record of no penalties or suspensions by the SFDA to date.
• Successfully handled 350+ medical device registrations with the GHFT & TFA routes.
• Handled 600+ Low Risk Medical Devices Registration (MDNR)
• Signed over 25 Authorized Representative Agreements and issued Authorized Representative License ARL.
• Elected as official to sign Authorized Representative Agreement with the manufacturer.
• Key Member of the ISO 13485:2016 audit for the regulatory department. Contributed to maintaining and promoting a constant state of readiness for audits and inspections.
• Bestowed with awards twice for recognition of outstanding performance/ individual contributor who has delivered top-line results.
Responsibilities:
• Commanding regulatory affairs initiatives- right from preparing regulatory affair dossiers for new products, identifying data requirements, assessment of requirements for registration to securing approval from regulatory agencies.
• Planning and executing Medical Device Registration with the GHFT & TFA registration routes.
• Overseeing the post market surveillance actives, to include that Field Safety Notice FSN are delivered to the health providers, and users of the medical device, recalling devices that are affected by corrective action, and coordinating with parties to process the required action as described by the manufacturer, control and follow up on adverse events cases and complaints till they are closed by the SFDA.
• Developing and evaluating the risk of potential regulatory strategies for new and modified products by performing assessments and analysis.
• Overseeing unique device identification (UDI) activities/meetings, which aids in specifically identifying devices and obtaining important descriptive information from the legal manufacturer to easily identify and trace any affected device variant by any vigilance activities such as FSN, recall, adverse event or complaint.
• Serving as the company’s key regulatory spokesperson and primary representative with SFDA, professional associations, special interest groups and the healthcare communities at large.
• Curating a team of specialized Regulatory Affairs professionals to bring the expertise and industry knowledge required to produce results.
• Training stakeholders on current and new quality and regulatory requirements to ensure organization-wide compliance.
Accomplishments as Product Specialist (March 2018 -January 2019):
• Proffered direction, leadership, and oversight required to deliver excellent results for penetrating new markets and achieving sustainable growth/P&L for the region.
• Under my assistance attained 82% sales target for the year.
• Played a pivotal role in achieving 75% of completing the requirements for the past receivables.
Responsibilities as Product Specialist (March 2018 -January 2019):
• Executed day-to-day business unit operations, strategy, partnered with high-performance sales & marketing teams for top & bottom-line financial impact & achieved extraordinary results.
• Commanded sales initiatives for the gynecology products portfolio. Defined business strategy, P&L roadmap and long-term strategic plans as well as ensured implementation in accordance with the Global Industry Standards.
• Partnered with a high-performing cross-functional team interfacing with product development, regulatory affairs, manufacturing, and post-market surveillance.
Accomplishments:
• Instrumental in successfully managing all flights for 2 hajj seasons.
• Hands-on experience in operating all 5 check-in systems for the flights. Trained Agents on the check-in process /system for each airline.
• Specialized in communication, client relations, operational support, and process improvement.
• Earned Recognition by Gulf Air as well as Royal Jordanian Airline.
Responsibilities:
• Teamed up to operate the flight check-in procedure as per the SOP. Completed pre-boarding checking procedures before passengers and flight board planes.
• Headed the team to complete the check-in process for all passengers in time and close the check-in on time.
• Catered to customer needs and resolved issues with compassion and understanding.
• Coordinated with the General Authority of Civil Aviation GACA and the airlines.
Previous Professional Experiences:
• May 2015 - July 2016: Business Development Manager, Alandijani General Contracting Est., Jeddah, Saudi Arabia
• January 2015 - June 2015: Retail Business Development Manager, Hempel A/S, Jeddah, Saudi Arabia
• August 2014 - January 2015: Marketing Executive - Retail Development, Jotun Saudi Arabia Ltd., Jeddah, Saudi Arabia
• February 2013 - July 2014: Marketing Executive, Jotun Saudi Arabia Ltd., Jeddah, Saudi Arabia
• October 2011 - September 2012: Assistant Relationship Executive, Arab National Bank, Jeddah, Saudi Arabia
BSc.: Marketing, King Fahd University of Petroleum & Minerals, Dhahran, Saudi Arabia, Feb 2011.