Aneela Lala Email & Phone Number

Auckland, New Zealand

Developing and executing a professional development strategy customised for the Active Medical Devices Technical Team within Regulatory Services (RS). Ensuring consistent delivery of an excellent professional development service to Technical Specialists, Scheme Managers, and Clinical Evaluation Specialists.- Accountable for leading and advocating for technical team’s professional development by ensuring a proactive approach in assessing the technical team training needs.- Supporting the technical teams in New Starter (NS) onboarding, Initial Training and Continuous Professional Development (CPD).- Supporting the strategy and implementation of a positive, client centric, collaborative, and agile working culture within the RS Professional Development team​

Auckland, New Zealand

Scheme Manager and Technical Expert for the Active Devices team at BSI Healthcare. Responsibilities include:- Technical & Unannounced Audits against MDR, ISO 13485 and associated standards. and requirements.- Perform peer reviews, technical training and mentoring as required.

Auckland, New Zealand

• Manage all company Regulatory Affairs and Quality Management functions to provide Quality Assurance over company functions.• Defining a Regulatory Strategy to achieve Market Access for intended sales territories including US, EU, UK, NZ, Australia and China. • Defining, delivering and monitoring Company Quality Objectives to ensure growth and efficiency.• Incorporate Regulatory Requirements into development and clinical trials activity, to ensure market entry approvals are obtained in a timely manner and product Regulatory Compliance is efficiently maintained.• Create, maintain and continually improve a practical Quality Management System to provide safety and reliability assurance over company activities and meet external authority and certification requirements.• Ensure compliance with QMS throughout the organisation by creating and delivering training programs, auditing of company outputs and overseeing critical processes.

Auckland, New Zealand

United Kingdom

- Leading a group of staff in the Active Medical Devices Team.- Managing a portfolio of Medical Device CE marking clients as Scheme Manager and Technical Expert- Delivering technical reviews in support of CE marking clients- Providing Medical Device expertise leadership and mentoring in areas of competence to Medical Devices personnel - Deputising for the Global Head, Active Medical Devices.- BSI Trainer to Internal and External Stakeholders on Medical Device related Standards and Regulations

United Kingdom

Scheme Manager and Technical Expert for the Active Devices team at BSI Healthcare. Experienced in auditing to the Medical Device Directive 93/42/EEC and FDA 510k submissions. A BSI trainer for MDD 93/42/EEC, ISO 14971, Post Market Surveillance and Vigilance, Process Validation and Technical File Writing.

Watford, United Kingdom

Management and development of the Smiths Medical International Technical Training business unit – including the delivery of training courses to internal and external stakeholders.Leading improvement projects within Technical Services and developing new opportunities within the marketplace.Management of key contracts to ensure profit maximization and customer retention.Ensuring key performance targets are managed and achieved.

United Kingdom

Technical support and training for manufactured medical devices to medical device technicians and end users.Specialising in syringe pumps, volumetric and ambulatory infusion devices, fluid warmers, gas powered emergency ventilators (including associated single-use patient gas circuits), patient vital signs monitors and gas powered anaesthesia machines.

United Kingdom

Technical support, installation and training for manufactured medical devices to medical device technicians and end users.Specialising in humidifiers, CPAP machines, infant warmers, gas driven infant resuscitators & accessories, nerve stimulators and associated single-use patient gas circuits.

Watford, United Kingdom

Technical support, installation and training for manufactured medical devices to medical device technicians and end users.Specialising in Syringe pumps, volumetric and ambulatory infusion devices and fluid warmers.

Auckland, New Zealand

Design, development and production of a Bluetooth wireless system to transmit biological signals from subject to monitoring system.Responsibilities included prototype assembly, testing and maintenance of electronic circuits, maintaining the implant in vivo. Technology included RF microprocessors and programming circuitry design, Bluetooth technology, Analogue & Digital circuit design, PCB design and C++ & PIC microprocessor programming

Be, Electrical & Electronic Engineering

New Zealand Certificate Of Engineering, Telecommunications Engineering