- Understanding of regulatory affairs and quality systems (ISO13485, GDPMDS) in the medical technology industry. Knowledge of regulatory requirements in the Singapore and ASEAN markets, EU MDR/IVDR a plus
- Strong ability to work together with people from different countries and backgrounds required - ability to listen and emphatise.
- Bachelor's degree in Science or Engineering.
- Strong multilingual skills preferred
- Singaporean or PR required
- Having a musical background preferred
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Regulatory Affairs Specialist
5 days ago
Johnson & Johnson SingaporeCaring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Joh ...
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Regulatory Affairs Specialist
1 week ago
Johnson & Johnson Singapore*** · The Regulatory Affairs Specialist has the responsibility to Supports regulatory department to ensure efficient and compliant business processes and environment. Assists in the registration of new products/changes/renewal licenses by preparing documentation needed for regist ...
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Regulatory Affairs Specialist
1 day ago
Boston Scientific Corporation Singapore**Work mode**:Hybrid**Onsite Location(s)**:Singapore, 01, SG**Summary** · Ensures rapid and timely approvals for respective product line by plans on all product registrations, manage all product registrations' preparation and documentation. Interacts with regulatory agencies' per ...
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Regulatory Affairs Specialist
1 week ago
CREDO DIAGNOSTICS BIOMEDICAL PTE. LTD. SingaporeParticipate in and contribute to regulatory strategy development and planning, including identifying regulatory risks and opportunities, and developing mitigation strategies. · - Maintains approvals/licenses/authorizations for existing marketing authorizations. · - Track regulato ...
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Regulatory Affairs Specialist
1 week ago
BRUNEL INTERNATIONAL SOUTH EAST ASIA PTE. LTD. SingaporeOur client is a MNC in the Medical Devices industry with a strong and expanding portfolio · **Roles and Responsibilities** · - Prepare and submit regulatory submissions, including product registrations, variations, and renewals, to regulatory authorities in APAC countries. · - De ...
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Regulatory Affairs Specialist
23 hours ago
TALENTSIS PTE. LTD. Singapore**Responsibilities**: · - Assess regulatory requirements and discuss regulatory strategies with the related staff for the qualifications of new products in Asia Pacific. · - Compile technical files, test reports and documentations necessary for regulatory submissions in the above ...
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Senior Specialist, Regulatory Affairs
1 week ago
ABBVIE SingaporePrimary Function / Primary Goals / Objectives: · The primary function of the Senior Specialist, Regulatory Affairs (RA) is to act as the representative of the regulatory affairs organization for all aspects related to the assigned therapeutic area and products of responsibility i ...
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Junior Regulatory Affairs Specialist
1 week ago
KANG SHI FU BEVERAGE SINGAPORE PTE. LTD. Singapore**Job Highlights** · Attractive Remuneration · Medical & Dental benefits · 5 Days Work Week · **Responsibilities**: · - Support the Regulatory Manager in daily tasks. Monitor, gather, verify, and interpret food and labeling regulations/standards, including potential revisions, fo ...
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Senior Regulatory Affairs Specialist
1 day ago
Johnson & Johnson Singapore**Overall purpose of job**: · - Ensure compliance to company SOPs and Quality Management System. · **Essential duties and responsibilities**: · - Ensure timely product registrations by internal timelines · - Prepare and maintain existing product licenses with updated CMC and CCDS ...
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Drug Regulatory Affairs Specialist
3 days ago
DADACONSULTANTS PTE. LTD. Singapore**Responsibilities**: · 1. Lead Document Preparation and Submission: · - Collaborate with internal teams to gather necessary documentation for IND submissions. · 2. Manage Drug Registration Process: · - Develop and execute regulatory strategies for drug registration submissions t ...
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Senior Regulatory Affairs Specialist
1 week ago
BAXTER Singapore**This is where you save and sustain lives** · At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves ...
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Regulatory Affairs Specialist Manager
1 week ago
SUNDAT (S) PTE LTD Singapore'- Source documents, consolidate file and maintain product technical information. · '- Handle product registration such as process registration and renewal with relevant authorities and keep track of the registration status. · '- Liaise with Laboratory on test and toxicity studie ...
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Senior Regulatory Affairs Specialist
1 week ago
BAXTER Singapore**This is where you save and sustain lives** · At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves ...
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Senior Specialist, Regulatory Affairs
1 week ago
BAXTER Singapore**This is where you save and sustain lives** · At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves ...
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Senior Regulatory Affairs Specialist/officer
3 days ago
Spring Professional (Singapore) Pte Ltd Singapore**Senior Regulatory Affairs Specialist/Officer (Distributor)** · Our client is a healthcare solution provider under one of the leading Life Sciences services companies in Singapore. · **Responsibilities**: · - Liaising with regulatory authorities for document preparation. · - Ens ...
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Specialist - Administrative Affairs (1-year
3 days ago
Reeracoen Singapore Pte Ltd SingaporeOur client is a major player in the home appliance and electronics industry. They are looking for a Specialist - Administrative Affairs (1-year Contract) to be in charge of support management and administrative functions. The incumbent will be reporting to the Manager / Head of t ...
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Regulatory Affairs Specialist medical Device
1 week ago
INTEGRITY PARTNERS PTE. LTD. Singapore**THE OPPORTUNITY**: · An esteemed **Medical Devices Company **is currently seeking a highly capable **Regulatory Affairs Specialist **to join their team. The successful incumbent will be tasked with the development and implementation of efficient regulatory strategies and proces ...
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Cochlear Ltd SingaporePrincipal Regulatory Affairs and Quality Specialist - AGM · **Job no**: 615794 · **Work type**: Permanent · **Location**: Singapore · **Categories**: Quality & Regulatory, Individual Contributor · **Cochlear's** mission is to help people hear and be heard. Around the world, more ...
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Philips Singapore**Job Title**: Senior Regulatory Affairs Specialist, ASEAN Pacific · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a bet ...
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Regulatory Affairs Specialist
4 days ago
Access-2-healthcare Singapore Full timeCompany Description · Access-2-Healthcare is a global consulting company dedicated to helping small to medium sized medical technology organizations overcome various challenges and launch their products in the market. Founded in 2015, the company has local offices in 14 countries ...
Regulatory Affairs Specialist - Singapore - ACCESS-2-HEALTHCARE
3 days ago
Description
Roles & ResponsibilitiesCompany Description
Access-2-Healthcare is a global consulting company dedicated to helping small to medium sized medical technology organizations overcome various challenges and launch their products in the market. Founded in 2015, the company has local offices in 14 countries and is dedicated to getting the job done by providing expertise to doctors, start-ups, universities, hospitals, and Med Tech communities. The company aims to increase the range of innovations available to hospitals, clinics and patients alike in an effort to lower healthcare costs.
Role Description
This is a contract role for a Regulatory Affairs Specialist. The Regulatory Affairs Specialist will be responsible for regulatory documentation, submissions, and requirements. This is an on-site role located in Singapore with very flexible working arrangements. Role able to gravitate to a permanent role.
Qualifications
FDA
Hospitals
Chinese
Music
Quality Management Systems
Regulatory Affairs
Healthcare
Risk Management
Biomedical Engineering
Surveillance
Medical Devices
Product Development
Software Development