Senior Regulatory Affairs Specialist

• May 2022 - Present

• Leading on Vision RT’s product submissions to competent authorities in line with the company global registration roadmap. • Develop and implement regulatory plans for new products. • Monitoring and analysing changes in the regulatory environment and implementing strategies for meeting new and changed requirements to ensure business continuity in target markets. • Liaising with internal and external stakeholders, providing training and support to ensure that regulatory requirements are met. • Preparing and submitting pre- and post-market reports to regulators and local representatives. • Planning and performing clinical evaluations of the company’s medical devices. • Maintaining Technical Documentation and ensuring compliance with applicable standards, regulations and guidance is documented. • Acting as an auditor of internal functions and external suppliers. Show less

Senior Regulatory Affairs Specialist

• Jan 2021 - May 2022

• International product registrations attending to individual country specific requirements; monitor and report progress. • Participation in cross-functional product development teams as the regulatory representative; development of regulatory strategies. • Assesses changes in regulations and helps to determine their impact. • Participate to the review of process/product changes, labelling, claims, product complaints, A&Ps (Advertising & Promotional materials), etc., to determine the need for any regulatory activities and to ensure compliance to international requirements. • Attends to audits performed by internal and external authorities to represent RA positions and processes. • Prepare regulatory dossiers for submission to Health Authorities and maintains them along the whole product life-cycle. Show less

Regulatory Affairs Specialist

• Oct 2019 - Jan 2021

• Manage CE and ISO certifications database for the Notified Body – including suspension, withdrawal and renewals.• Conduct First Pass Filter document reviews of Technical Documentation for CE marking.• Review and provide client feedback for Manufacturer Change Notification submissions. • Establish, log and manage Technical File Assessment projects in adherence to milestones.• Support UL process and tool development to manage client expectations.• Manage and monitor work flow and budgets to support monthly/ annual workflow in-line with business targets.• Identify resource requirements and assign to specific projects.• Review client Medical Device applications for CE marking, provide feedback and open projects as necessary.• Ensure document management and handover between Notified Body, Internal stakeholders and clients.• First hand support of client technical queries/ issues. Show less

Regulatory Technical Specialist

• Oct 2018 - Oct 2019

• Review and disseminate regulatory intelligence to ensure up to date information is available to internal stakeholders.• Manage device review and registration database.• Provide SFDA internal stakeholders with MDD/ ISO training and TF reviews. • Review of active and non-active Medical Devices Marketing Authorizations (MDMA) applications in accordance with the Saudi Medical Devices Interim Regulations - Ensuring Medical Devices are in compliant with applicable regulations in one of the 5 GHTF countries: EU (MDD/IVD/AIMD), USA (510(k), PMA, QSR), Canada (SOR/98-282), Japan (JPAL), and Australia (Australian MD Regulations). Technical reviews cover, but not limited to:- Indications for use, classification and labelling and clinical claims; - Audit reports and ISO 13485 Certificates;- Market clearance documentation (e.g. EC Certificates, DesignExamination Certificates);- 510k clearance letters, HC licenses, PMA approvals, IR reportsDOC’s. Show less

Regulatory Affairs Projects Lead

• Dec 2017 - Oct 2018

• Manage the implementation of ISO 13485:2016, including updates to the QMS across all sites of the organisation for successful certification.• Work with internal business functions to lead the initial planning and implementation of the EU-MDR The European Medical Device Regulation (MDR 2017/745).• Manage and implement the requirements of the Falsified Medicines Directive with Serialisation and Tamper Evident solutions on customer combination products.• Data Integrity (FDA & MHRA requirements): Assessing all company's systems and processes for Data Integrity. Gaps were risk assessed, mitigated and actioned for closure.• Manage successful ISO 13485:2016 Certification Audit of the OM Malaysian Manufacturing facility.• Approve of documents in areas of responsibility; writing, developing and training Standard Operating Procedure.• Manage projects with key stakeholders including Sales & Marketing, Quality, R&D and clients to plan and execute efficient regulatory routes to market.• Support project plans, timelines, cost and resource planning across the business and provide updates to senior management.• Support CE and ISO audits performed by internal and external authorities to represent RA positions and processes. Show less

Regulatory Affairs Officer - Projects

• Oct 2016 - Dec 2017

• Create and maintain Class 1 – IIb Technical Files (EU-MDD 93/42/EEC).• Compile technical documentation for drug-device combination products – MA approved drugs.• Successful compilation and submission of an FDA Class II sterile device (510k). • Compile Device Master Files (DMF) for combination products to support IMP/ NDA FDA submissions.• Successful FDA Pre-submissions for Sterile devices..• Support timely product registrations in global markets, i.e. US, EMEA and Asia Pacific, and managing the regulatory database.• Manage and compile regulatory strategies to bring various products to market.• Reviewing product labelling for regulatory compliance for CE marked devices and to appropriate requirements of ROW markets.• Advise and support internal stakeholders and clients on regulatory requirements.• Liaising with the MHRA and Notified Body to ensure product compliance is maintained. Show less

Pharmaceutical Project Coordinator - Biomedical

• Jul 2014 - Oct 2016

• Compile and maintain technical documents through the design and development of an innovative combination product. • Keep up to date with appropriate regulations. • Assist in the creation and development of the regulatory strategy. • Provide first hand comprehensive administrative support to core team operations. • Support in the project plans and budgeting. • Compile and maintain technical documents through the design and development of an innovative combination product. • Keep up to date with appropriate regulations. • Assist in the creation and development of the regulatory strategy. • Provide first hand comprehensive administrative support to core team operations. • Support in the project plans and budgeting.

Project Assistant

• Aug 2013 - Jul 2014

Responsibilities • Supporting project meetings, client visits, marketing strategies, artwork and illustrations of marketing material • Organising and leading frequent promotional events • Writing reports, company brochures and online content • Ensuring client requirements are met according to company standards • Collaborative team support Responsibilities • Supporting project meetings, client visits, marketing strategies, artwork and illustrations of marketing material • Organising and leading frequent promotional events • Writing reports, company brochures and online content • Ensuring client requirements are met according to company standards • Collaborative team support

Teaching Assistant and Language tutor

• Feb 2013 - Jul 2014