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.
- Company industry:
- Medical & Healthcare Equipment
- Job role:
-
Management
