Management System and Regulatory Consultant

1 week ago


Singapore YNL 360 PTE. LTD. Full time

**What does Stendard do?**:

- We are a regulatory consultancy and technology company that helps businesses implement international standards, streamline business processes across the organisation, and accelerate global growth.**Stendard Solution**:

- From setting up your QMS with a complete set of documents to maintaining your QMS through proper document version control and automated workflow processes, you will find valuable features tailored to your organisation, regardless of whether you are a start-up or an established organisation.- Our software is specially created to help you manage your documents, business process workflows and team collaboration without the usual print-sign-store system, which is unsustainable, slow and expensive to maintain.**Roles and Responsibilities**:
**Consultancy**:

- Guide and train clients on the implementation of various standards
- Communicate with clients on project related matters
- Work with project manager to assist and ensure proper and timely implementation of consulting projects’ milestones
- Evaluation of client's existing processes by conducting Gap Analysis and providing recommendations on how to improve them for compliance to ISO 13485:2016, ISO 27001:2022, ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 22000:2018 and other relevant standards
- Conducting second and third party audits for clients to prepare them for the certification audit.
- Support the identification of any clients’ internal QMS issues (Feedback and complaints, NCs, Change Control, CAPAs) and propose rectification action
- Coordinate clients’ departments to be prepared for certification audit
- Be present at clients’ certification audit when needed
- Ensure that clients’ processes needed for the Management System (MS) are documented
- Reporting to the clients’ top management on the effectiveness of the MS and any need for improvement
- Ensure that clients’ documents are reviewed and approved by relevant personnel
- Monitor creation of clients’ records and ensure relevant review and approval processes are completed
- To understand the clients’ businesses and nature of the product, and to lead and manage the project through the execution from a Regulatory Strategy, Gap Analysis, Technical Dossier Preparation, Content sufficiency guidance to the Submission and maintenance of communication with the regulatory bodies (Europe MDR/IVDR, United States FDA, Singapore HSA, Japan PMDA, South Korea MFDS etc.) and partners to achieve successful registration of the products in various countries
- Maintenance of client's licence holding activities.

**Stendard Solution**:

- Incorporate the usage of Stendard SolutionTM as part of your consultancy roles and responsibilities
- Assist in the improvement of software features by taking on various projects, supporting the development of Stendard SolutionTM features
- Be part of the exciting team to translate customer feedback and learning into new Stendard SolutionTM software offering/features as continuous innovation and translating that into engineering work.

**Business Development**:

- Support the Business Development team during lead engagement activities as the technical expert on specific standards
- Communicate with the Business Development team on project progress.



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