Senior Regulatory Affairs Compliance Specialist

• Mar 2023 - Present

Regulatory Affairs Compliance Specialist

• Feb 2021 - Present

Quality Manager

• Oct 2019 - Feb 2021

• Manage Quality Assurance function for developing third generation of integrated systems, which can be used by consumers and their healthcare service providers using a wide range of software platforms or devices to better enable effective and easy self-monitoring; • Review and complete records to ensure compliance with ISO 13485:2016, EU MDD 93/42/EEC, MDR2017/745 NHS Data Security and Protection toolkit; • GAP analysis and documentation preparation for the new MDR 2017/745; • Quality leader in multi-year project to design and implement Aseptika products as class I and Class IIa medical devices; exposure to registering software as a medical device; • • Provide compliance and technical leadership to the Product Development, Software development and Manufacturing in resolution of investigations and assessment of proposed changes. • Assist in the review of operational procedures, training materials and procedures for various systems; • Develop the product risk management capabilities and tools within Team, through coordinating risk management activities and coaching others to develop risk management competencies, FMEA, including the Privacy Impact Assessments; • Oversee Customer Complaint Handling System and trend analysis, CAPA and supplier quality improvement programs; • Liaise with suppliers with respect to quality aspects/quality agreements in supporting existing business and new product introductions; working with vendors in case of non-conforming materials; • Working with purchasing to establish product quality requirements and quality control documentation. • Create and manage the Design History Files / Technical Files, Clinical evaluation documentation; • Responsible for final batch release inspection ensuring batch release times and all associated metrics are achieved; • Complete and host the regulatory audits as required; • Support and perform Quality Internal Audit . Show less

General Ledger Accountant

• Jan 2019 - Oct 2019

Reconciliation Agent at Paysafe Group

• May 2015 - Dec 2018

• Responsible for several high-profile banks, ensuring they are monitored and any issues promptly dealt with. • Responsible for month end bank reconciliations and ensuring all costs are correctly coded. • Reconciliation of Credit Cards, UK Direct Debit, SEPA DD, GL Accounts in multiple currencies, Fixed Assets • Set-up and preform G/L reconciliations monthly to verify the integrity of account balances on the chart of accounts. • Process improvements. Drive, challenge and support team to implement the assigned process improvement initiatives, aiming to automate daily and month-end tasks • Meet month-end and other deadlines set by HOF/Divisional CFO by carrying out assigned tasks in a timely manner, ensuring completeness, accuracy and effective distribution and monitoring of workload amongst team members • Profitability analysis. MOM variance analysis of revenue and costs associated with each merchant. Investigating negative profitability. Ensuring all key stakeholders are aware of findings to take corrective action • Work with the Head of Finance and Divisional Controllers to ensure a clean and timely year end audit. • Monitor, analyse, and coordinate department work to maximise use of resources while maintaining a high level of accuracy • Posting Accruals and prepayments. • Estimated and reversal of VAT Show less