If you aspire to contribute to the medical industry, we invite you to join our dynamic team which supports the Medical Directors and medical staff of Raffles Hospital in delivering healthcare of the highest professional and ethical standards
Job Responsibilities
In this role, you will collaborate with various stakeholders to execute the following
Deliver medical affairs services to support medical staff
Manage credentialing and accreditation of medical staff
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The upcoming Eastern General Hospital (EGH) aspires to provide excellent, patient-centred care and to improve the health of the population in the east of Singapore. We aim to develop future-ready systems to support patients’ healthcare journeys and to be an employer of choice for our staff.
You will be part of the team responsible for the implementation of the various functions and sections of the Clinical Services to ensure compliance with relevant clinical statutory and regulatory requirements and proper discharge of obligations under the Ministry of Health’s Service Level Agreement.
You will supervise the Clinical Services and Medical Affairs staff in developing clinical governance frameworks and policies, improving professional and clinical quality and practice as well as overseeing the Clinical Notes Review Programme to meet regulatory requirements at different project phases of the Hospital building.
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· Manages devices products related lifecycle activities for the assigned projects to ensure regulatory requirements are met
· Supports JAPAC Area RA Lead, affiliates and Global Regulatory Affairs in variation related activities (i.e. regulatory assessment, etc.) for the assigned projects
· Implements regulatory strategies for the assigned projects for countries in JAPAC under supervision, in line with area commercial priorities and in collaboration with the Global Regulatory Lead and other RA sub-team colleagues.
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· Manages devices products related lifecycle activities for the assigned projects to ensure regulatory requirements are met
· Supports JAPAC Area RA Lead, affiliates and Global Regulatory Affairs in variation related activities (i.e. regulatory assessment, etc.) for the assigned projects
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, Regulatory Affairs (RA) is to act as the representative of the regulatory affairs organization to the JAPAC commercial organization for all aspects related to the assigned projects within the Aesthetics area. The incumbent will have knowledge of the regulatory requirements of the countries within the region. Under guidance, he/she will combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The incumbent will also represent RA in any cross-functional initiatives being led out of the JAPAC commercial offices or the global RA organization.
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
We are looking for a Associate Director, Medical Affairs Biopharma, Southeast and South Asia. As an Associate Director Medical Affairs, the main purpose of your role will be to build partnerships with external healthcare professionals in Southeast and South Asia, to communicate evidence based critical scientific, technical, and development issues relating to Grifols Biopharma products which are or will be marketed. You will have the chance to manage a team.
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5-day work week: Mondays to Fridays
Easily accessible from MRT Station Central Location
Competitive salary and benefits
A US Based MNC in the distribution/ manufacturing of Medical Devices, is seeking for an experience and suitable candidate to join the growing team!
Job Responsibilities:
Participate and coordinate in the development of regulatory strategies based on the needs of the company for each product range and change
Conduct regular review with the Sales and Marketing and other relevant stakeholders to ensure strategies are align to company's needs and marketing strategies
Liaise and work closely with all relevant internal and external parties to understand and evaluate the requirements for product registrations for the assigned market
Manage the preparation of submissions for new products, amendment/ variation of approved products and submissions that support the maintenance of existing licenses
Monitor and update registration activities and/ or status to all relevant stakeholders on a regular basis
Ensure timely approval of registration in target market
Manage changes to licenses due to product/ manufacturing related changes to minimize/ prevent risk and impact to the business
Monitor license expiry and establish routine follow up with the affected countries to ensure license renewal be conducted in a timely manner
Ensure on time reporting on any adverse events to authorities review complaints for potential adverse events and submit reports to appropriate agencies
Maintain quality system/ GDP procedures and support on-site audit for Malaysia establishment
Establish and maintenance of commercial Quality Management System and certification according to the Company's QA and country regulatory requirements
Participate in both internal and external Quality System Audit e.g. GDPMS certification
Act as the management representative for Singapore and Malaysia to oversee compliance of business operations as per company GDP and GDPMDS guidelines and requirements
Assist QA Management in preparation of materials and follow up actions for Management Reviews and meetings
Responsible for document control, change control and training management
Monitor and ensure activities required for maintenance of QMS are performed, including risk management, supplier management and qualification management
Handle post market surveillance activities e.g. product complain, recall, AE reporting, vigilance reporting, FSCA execution and closure
Coordinate the Corrective and Preventive Action (CAPA) system and monitor to ensure timely closely
Cross function collaboration to create and upload SOPs/ Work instructions
Implement product relabeling/ packaging required as per country's labeling requirements
Job Requirements
Minimum Diploma/Bachelor's degree or equivalent in relevant field
Minimum 3 years of regulatory experience in medical device industry for SEA+ region
Individuals who have obtained a Regulatory Certification are a plus
Some prior experience working for a medical device manufacturer establishing and maintenance of commercial Quality Management System and certification SS620/GDPMDS/ISO13485 internal auditor certified will be advantageous
Interested and suitable candidates, please email your CV in MS Word to
Ammerline Lam Sze Yi
CEI Reg. No.: R1104463
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Reporting tothe Assistant Director, you will be part of a dynamic team working closely withclinicians and administrators. You will be responsible for managing medicalrelated feedbacks which includes conducting investigations, facilitating familyconferences, coordinating mediation meetings and institution reviews. Inaddition, you will assist the Assistant Director with matters relating tomedical-legal cases. You will have to manage and provide appropriate responsesto the feedback received by the Institution in a timely manner.
**Our client is an established company specialising in Biomedical and Manufacturing. They are expanding and growing at a fast pace and now looking to hire a Regulatory Affairs (RA) Executive to support the growth. They are located in the West - easily accessible.
The Duties of Regulatory Affairs Executive include:
...
**Our client is an established company specialising in Biomedical and Manufacturing. They are expanding and growing at a fast pace and now looking to hire a Regulatory Affairs (RA) Executive to support the growth. They are located in the West - easily accessible.
The Duties of Regulatory Affairs Executive include:
...
**Our client is an established company specialising in Biomedical and Manufacturing. They are expanding and growing at a fast pace and now looking to hire a Regulatory Affairs (RA) Executive to support the growth. They are located in the West - easily accessible.
The Duties of Regulatory Affairs Executive include:
...
**Our client is an established company specialising in Biomedical and Manufacturing. They are expanding and growing at a fast pace and now looking to hire a Regulatory Affairs (RA) Executive to support the growth. They are located in the West - easily accessible.
The Duties of Regulatory Affairs Executive include:
...