Fikriansyah
Medical Device Reviewer
Summary
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Scientific-inclined mind with extensive experiences in regulatory framework, policy and analysis. Spearheaded various health administrative initiatives through managing projects and performing analysis for improving health outcomes.
Overview
9
9
years of professional experience
6
6
years of post-secondary education
Work History
Medical Device Reviewer
Ministry of Health of the Republic of Indonesia
Jakarta
08.2022 - Current
- Reviewed the design dossiers/technical documentation independently or as a team of evaluators for a range of medical devices with the goal of verifying whether the devices meet the requirements of the relevant standards/regulation before entering the market.
- Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
- Managed the public and stakeholder consultation platforms regarding policy implementation updates, issues, and concerns related to medical device marketing approval
- Excellent communication skills, both verbal and written.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Analyzed the list of medical devices on e-catalogue platform for ‘freeze/unfreeze' decision on then imported products substitution initiative.
- Consolidated the content of Pharmaceutical and Medical Devices Dictionary (KFA) System for Indonesia Master Data on the effort of digitalization.
- Participate in standardization, technical, and/or regulatory workshops or speaking events as well as responsible for the execution of training sessions based on the global training curriculum for regulators.
- Delivered services to customer locations within specific timeframes.
Transformation Officer
Centre for Health System and Strategy– Ministry of Health Indonesia
Jakarta
01.2022 - 07.2022
- Led and designed the programs for medical device local production improvement initiatives with different directorates and stakeholders.
- Managed the strategic approaches to the Indonesia G20 Presidency Health Track priority issues on pandemic prevention, preparedness and response, information dissemination to public and stakeholder consultation.
- Facilitated the conduct of dissemination meetings related to the Minister of Health with related ministries, key partner organizations, and stakeholders
- Gathered, documented, and modeled data to assess health system transformation pathways.
- Reviewed internal systems and organized training plans to address areas in need of improvement.
- Restructured procedures through coordination with compliance director to create and execute projects.
- Conducted thorough reviews of operations to devise and deploy improvement strategies.
COVID-19 Community Engagement Team Member
Star Health Group
Melbourne
11.2020 - 12.2021
- Ensured the safety of the High-Risk Social Housing Residents by disseminating the updated COVID-19 measurements in place.
- Developed and implemented communication strategies with Health Promotion approach.
- Conducted analysis of community needs and resources to support strategic plan especially during the COVID-19 outbreak.
- Collaborated with numerous organizations to create large-scale events, including the City of Port Philips and City of Stonnington.
- Coordinated and implemented mailings for recruitment and education programs.
Medical Device Reviewer
Ministry of Health of the Republic of Indonesia
Jakarta
12.2016 - 12.2019
- Managed the public and stakeholder consultation platforms regarding policy implementation updates, issues, and concerns related to medical device marketing approval.
- Coordinate with other product reviewers/evaluators, clinical experts, process experts, technical experts, and the certification project managers to meet the review timelines, provide quality review reports and ensure the consistency of the information via the consolidation of the review/assessment.
- Assisted in the conduct of dissemination meetings related to medical device regulatory policy development with related ministries, key partner organizations, and stakeholders.
- Coordinated and prepared the directorate's budget plan annually through effective monitoring and evaluation to strengthen the pre-market surveillance, monitoring, and evaluation systems for medical devices.
- Gained extensive knowledge in data entry, analysis and reporting.
- Initiated the implementation of e-government approach throughout the whole medical devices registration platform.
- Proven ability to develop and implement creative solutions to complex problems.
- Excellent communication skills, both verbal and written.
- Delivered services to customer locations within specific timeframes.
Executive Assistant to The Director General
Ministry of Health of the Republic of Indonesia
Jakarta
07.2015 - 11.2016
- Demonstrated creativity and resourcefulness through the development of innovative solutions.
- Worked flexible hours across night, weekend and holiday shifts.
- Self-motivated, with a strong sense of personal responsibility.
- Developed and maintained courteous and effective working relationships.
- Passionate about learning and committed to continual improvement.
- Gained strong leadership skills by managing projects from start to finish.
Administrative Staff Member
Ministry of Health of the Republic of Indonesia
Jakarta
04.2015 - 06.2015
- Drafted professional memos, letters, and marketing copy to support business objectives and growth.
- Updated spreadsheets and databases to track, analyze, and report on medical devices data.
- Edited documents to improve accuracy of language, flow, and readability.
- Booked airfare, hotel, and ground transportation to coordinate office travel.
- Organized logistics and materials for each meeting and took detailed notes for later dissemination to key stakeholders.
- Facilitated timely delivery of special projects to meet organizational and departmental objectives.
Research and Development Analytical Intern
PT Bintang Toedjoe
Jakarta
03.2014 - 05.2014
- Identified issues, analyzed information and provided solutions to problems.
- Self-motivated, with a strong sense of personal responsibility.
- Ran errands and provided general office support in a professional environment.
- Cultivated interpersonal skills by building positive relationships with others.
- Demonstrated creativity and resourcefulness through the development of innovative solutions.
Pharmacist Trainee
UII Farma Pharmacy
Yogyakarta
01.2014 - 02.2014
- Educated patients on possible drug interactions, potential side effects, and optimal methods of administration.
- Provided friendly customer service at drop-off and pick-up counters.
- Educated patients on the importance of vaccination to provide immunity against influenza, pneumonia, and other diseases.
- Prepared packaging and labels for prescriptions, verifying accuracy of dosage, side effects, interactions, and refill instructions.
Education
Master of Public Health - Global Health, Health Economics, Health Promotion
University of Melbourne
Melbourne, Australia 03.2021 - 01.2022
Pharmacist Profession Program - Analytical Development And Community
Universitas Gadjah Mada
Yogyakarta, Indonesia 09.2013 - 08.2014
Bachelor of Pharmacy - Life Sciences And Pharmaceutical Industry
Universitas Gadjah Mada
Yogyakarta, Indonesia 08.2009 - 11.2013
Skills
Medical Devices Regulatory
undefinedTimeline
Medical Device Reviewer
Ministry of Health of the Republic of Indonesia
08.2022 - Current
Transformation Officer
Centre for Health System and Strategy– Ministry of Health Indonesia
01.2022 - 07.2022
Master of Public Health - Global Health, Health Economics, Health Promotion
University of Melbourne
03.2021 - 01.2022
COVID-19 Community Engagement Team Member
Star Health Group
11.2020 - 12.2021
Medical Device Reviewer
Ministry of Health of the Republic of Indonesia
12.2016 - 12.2019
Executive Assistant to The Director General
Ministry of Health of the Republic of Indonesia
07.2015 - 11.2016
Administrative Staff Member
Ministry of Health of the Republic of Indonesia
04.2015 - 06.2015
Research and Development Analytical Intern
PT Bintang Toedjoe
03.2014 - 05.2014
Pharmacist Trainee
UII Farma Pharmacy
01.2014 - 02.2014
Pharmacist Profession Program - Analytical Development And Community
Universitas Gadjah Mada
09.2013 - 08.2014
Bachelor of Pharmacy - Life Sciences And Pharmaceutical Industry
Universitas Gadjah Mada
08.2009 - 11.2013
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