Head Of Compliance
CurrentLeading domestic and global regulatory strategies and ensuring continued improvement of the management systems, in-line with ISO 13485 and ISO 27001
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Nikita Fernandes is listed as Head of Compliance at SiSU Health Group, a with 40 employees, based in Melbourne, Victoria, Australia. AeroLeads shows a matched LinkedIn profile for Nikita Fernandes.
Nikita Fernandes previously worked as Private Tutor at Ezymath Tutoring and Quality and Regulatory Affairs Associate at Maxoniq. Nikita Fernandes holds Master Of Engineering - Meng, Biomedical/Medical Engineering from University Of Melbourne.
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I am a Quality and Regulatory Affairs Associate, with experience in ISO 13485 and Medical Device Regulations in Australia (under MDSAP). I completed a Master's in Biomedical Engineering at the University of Melbourne in 2023, where my curiosity for the niche field of regulation and quality compliance was piqued. My technical skills include conducting internal ISO 13485 audits and supplier ISO 13485 and ISO 9001 audits and assessing product conformance pre- and post-manufacturing. Additionally, I have a broad range of expertise in staff and project management where I ensure continual regulatory and quality compliance. Lastly, I am experienced in liaising with Australian and international regulatory consultants, where I have the opportunity to gain knowledge and expertise from specialists in medical device regulations.In addition to my technical skills, I enjoy continually improving myself both personally and professionally. More recently I have implemented my coding skills to learn a new coding language and automate processes within the Customer Relationships Manager used in my current role. In my personal life, I have taken on various projects including tinkering with electronics, improving my musical abilities and attempting polyglotism
Listed skills include Project Management, Team Leadership, Working With Children, Management, and 6 others.
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Melbourne, Victoria, Australia
Leading domestic and global regulatory strategies and ensuring continued improvement of the management systems, in-line with ISO 13485 and ISO 27001
Victoria, Australia
As a private tutor as EzyMath Tutoring, I provide individualised lessons to students and accelerate student's academic achievement.Key Achievements:- Encouraging students affected by online teaching during the pandemic to achieve and surpass their learning goals,- Tutoring 4 students who have shown significant improvements with their grades.- Coaching 3 students for entrance exams to prestigious schools and colleges, of which 1 has applied and gained entry.- Providing a consistent study strategy that will help beyond mathematics- Enhancing youth development by encouraging active learning methods and asking questions
Carlton, Victoria, Australia
MAXONIQ is a medical device company that specialises in patient-specific oral and maxillofacial surgical devices. As the Quality and Regulatory Affairs Associate, I manage, maintain and internally audit the company's ISO 13485 certified Quality Management System to ensure that all Quality Operating Procedures are upheld. I also oversee a regulatory portfolio of ARTG listed medical devices ranging from Class I to Class IIb.
Melbourne, Victoria, Australia
As an engineering intern, I took part in the research and development of maxillofacial prostheses.Key Achievements:- Completed a research literature review on improvements to an existing medical device, to reduce post-surgical recovery. - Provided design improvments for surgical drilling guides which were accepted by the surgeon and have since been approved for use in future cases. - Completed finite element analysis on an existing device to gain an understanding of the impact of screw placement during surgery.
Brighton, Victoria, Australia
As a sales assistant at Kidstuff, I was responsible for actively selling and merchandising children's books, educational materials, and toys. My other responsibilities included - handling payments, assisting customers with inquiries and promoting products and services to the customers.Key achievements:- Oversaw maintenance of visual merchandising standards for customer satisfaction by promoting and improving sales of discontinued stock by 60%- Supervised and provided training to 3 junior seasonal staff- Completed stock take and merchandising of deliveries usual and seasonal deliveries, up to 4 pallets per day.- Organised displays for active promotions- During online sales, provided customer support and handled customer queries.
Clayton, Victoria, Australia
As a teaching assistant at Monash University, I was responsible for marking and delivering feedback to students' reports, assignments and exams.Duties:- Handled student's queries and questions during classes.- Provided feedback form students to the subject coordinators
Melbourne, Victoria, Australia
As tutor at Kumon Australia & New Zealand, I was responsible for providing individualized lessons to students while accelerating students' academic achievement.Key Achievements:- Taught up to 5 young students at a time, basic literacy and numeracy skills, and facilitated language development in a classroom environment- Coached older students and encouraged them to pursue mathematics beyond their school year level. Most students were 2-3 years ahead of the assigned grade.
Dandenong, Victoria, Australia
While working as a retail assistant at Goldmark Jewelers I provided feedback and was heavily involved in merchandising the premises. I also implemented daily sales targets to motivate team members to achieve target KPIs.Key achievements:- Assigned as Key Holder and was involved in junior staff management- Coached new staff to efficiently memorise the 5-Star selling method to boost store sales- Improved store morale by facilitating budget targets for each staff member and friendly competition. This allowed the team to reach weekly targets at least 2 out of 4 weeks in the month
Other employees you can reach at sisuhealthgroup.com. View company contacts for 40 employees →
Patrick J Hannebery
Colleague at Sisu Health GroupGreater Melbourne Area, Australia
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Tom Vogel Pisel
Colleague at Sisu Health GroupMelbourne, Victoria, Australia
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Franchesca Lafontaine
Colleague at Sisu Health GroupSpringfield, Massachusetts, United States
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Andrew Caluzzi
Colleague at Sisu Health GroupMelbourne, Victoria, Australia
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Fish Toad
Colleague at Sisu Health GroupNigeria
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Shilpa Shivakumar
Colleague at Sisu Health GroupAustralia
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Kieren Coates
Colleague at Sisu Health GroupMelbourne, Victoria, Australia
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Simon Skruzny
Colleague at Sisu Health GroupBurwood, Victoria, Australia
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Sarah Pearce
Colleague at Sisu Health GroupMarlow, England, United Kingdom
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Maree Duncan
Colleague at Sisu Health GroupHawthorn, Victoria, Australia
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Activities and Societies: Melbourne University Bio-Innovation Design (MBSI) competition participant. Melbourne University Biomedical.
Analysed data relating to the development of neural changes in the days to weeks after traumatic brain injury
Activities and Societies: Mentored students for the International Conference of Undergraduate Research (ICUR) as part of the Centre.
Quick answers generated from the profile data available on this page.
Nikita Fernandes works for SiSU Health Group.
Nikita Fernandes is listed as Head of Compliance at SiSU Health Group.
Nikita Fernandes is based in Melbourne, Victoria, Australia while working with SiSU Health Group.
Nikita Fernandes has worked for Sisu Health Group, Ezymath Tutoring, Maxoniq, Kidstuff Pty Ltd, and Monash University.
Nikita Fernandes's colleagues at SiSU Health Group include Patrick J Hannebery, Tom Vogel Pisel, Franchesca Lafontaine, Andrew Caluzzi, and Fish Toad.
You can use AeroLeads to view verified contact signals for Nikita Fernandes at SiSU Health Group, including work email, phone, and LinkedIn data when available.
Nikita Fernandes holds Master Of Engineering - Meng, Biomedical/Medical Engineering from University Of Melbourne.
Nikita Fernandes is listed with skills including Project Management, Team Leadership, Working With Children, Management, Data Analysis, Education, Retail, and Teamwork.
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