Total 1,561 Project Development Manager job vacancies in Quality Assurance / Control category in The United States of America

Job Responsibilities:

1. New product registration:

• Prepare and compile registration dossiers in accordance with relevant regulatory requirements including: 
  

  • Constructing/ editing letters of response/ justification/ declaration and clinical documentation for submission packages in accordance with guidelines checklists.

  • Compile/ review/check material for dossier prior to submission, incorporate feedback from relevant stakeholders.

  • Conduct checks on artworks to ensure in compliance with local regulation.

• Submit product registration applications to local health authorities  according to target submission timelines.
• Liase with and respond to additional requests or queries from health authorities and follow up (when necessary) until approval per target timelines.
• Liase with enternal and external stakeholders/ departments to build rapport and to achieve target outcomes.

2. Comply with regulatory requirements: to maintain validity of existing licenses/ certification/ authorization (e.g, product licenses, manufacturing licenses, establishment license, GDPMD licenses, import/ export license) through timely variations and/ or renewals to ensure supply continuity.

3. Keep abreast of regulatory updates from health authorities in the drugs, cosmetics, and medical device space.

• Assess regulatory updates on impact to business and communicate insights on approach to handle affairs.
• Propose solutions to arising issues.

4. Update and maintain database of regulatory and product registration information.

5. Good maintenance of final submitted documentation and local repository.

6. Ensure compliance with quality procedures stipulated for regulatory affairs, its administartive maintenance, and plan/ suggest improvements to operations.

7. Support any audits or inspections.

8. Guide/ oversee work performance and development of direct report.

9. Provide input for periodic operation metrics/ budget initiatives by managing  operating expenses within approved budget for the year.

10. Handle any other assingment as advised by supervisor.

 

Requirements: 

• Possess a Bachelor Science
• Work experience in regulatory affairs.
• Familiar with drugs/ cosmetics/ medical device regulatory landscape and GxP related matters.
• Proficiency in Microsoft Office Applications and relevant regulatory system software.
• Adopt good practices in documentation and communication.

Perks & Benefits

• Allowance ( mileage,transportation)
• Medical insurance

工作職責：

1、新產品註冊：

• 根據相關監管要求準備和編制註冊檔案，包括：
  

  • 根據指南清單建立/編輯提交包的回應/理由/聲明和臨床文件。

  • 在提交之前編譯/審查/檢查檔案資料，納入相關利害關係人的回饋。

  • 對藝術品進行檢查，以確保符合當地法規。

• 根據目標提交時間表向當地衛生部門提交產品註冊申請。
• 與衛生當局聯絡並回應其他請求或詢問，並跟進（必要時）直至按照目標時間表獲得批准。
• 與內部和外部利害關係人/部門聯絡，建立融洽關係並實現目標成果。

2. 遵守監管要求：透過及時變更和/或更新來維持現有許可證/認證/授權（例如產品許可證、製造許可證、企業許可證、GDPMD許可證、進出口許可證）的有效性，以確保供應連續性。

3. 隨時了解衛生當局在藥品、化妝品和醫療器材領域的最新監管動態。

• 評估監管更新對業務的影響，並就處理事務的方法傳達見解。
• 針對出現的問題提出解決方案。

4.更新和維護監管和產品註冊資訊資料庫。

5. 妥善維護最終提交的文件和本機儲存庫。

6. 確保遵守監管事務、行政維護規定的品質程序，並規劃/建議營運改善。

7. 支持任何審計或檢查。

8. 指導/監督工作績效和直接報告的發展。

9. 透過在年度核准的預算內管理營運費用，為定期營運指標/預算計畫提供輸入。

10. 處理主管建議的任何其他分配。

要求：

• 擁有科學學士學位
• 監管事務方面的工作經驗。
• 熟悉藥品/化妝品/醫療器材監管環境和 GxP 相關事宜。
• 熟練Microsoft Office應用程式和相關監管系統軟體。
• 在文件和溝通方面採用良好的做法。

津貼和福利

• 津貼（里程、交通）
• 醫療保險

Introduction to the role:

Our Client a MNC fintech giant is looking for a Compliance Project Manager.

Key Responsibilities:

· Understand the business requirements and propose an end-to-end system and operational solution for the Unsecured Lending, Cards & Payments Business.

· Act as a bridge between the Product Managers and the Operations/Technology teams, where applicable to communicate the business requirements effectively.

· Have an in-depth technical understanding of finance compliances and liaise on them with the product manager and IT to get them tracked and executed. Worked on devising high level approach in conjunction with IT colleagues, to ensure the business interests are met.

· Manage, coordinate and prioritise the Unsecured Lending, Cards & Payments Business related enhancement & Projects.

· Participate in innovative project development and implementation, where appropriate.

· Support Cross-functional projects with teams from operations, technology and other partners through a collaborative approach that supports project objectives.

· Responsible for managing a team comprising of test analysts to support the above business lines.

· Provide leadership and work closely with the test analysts to support the test cases design, coordination, preparation, and execution under the UAT phase leading to deployment.

· Exercise judgment by clarifying on the tasks, deliverables, and provides leadership to the test analysts.

Requirement:

· Degree in Computer Science, Business Information Systems or equivalent area of study

· Good understanding of project & test methodology and experience in a SDLC and other methodologies (Agile etc).

· Prior experience working in Singapore/APAC with at least 8 or more years of relevant working experience.

· Prior experience with finance compliance projects is a must.

· Familiar with AS400 environment or similar card systems platform.

· Possess good knowledge in for Unsecured Lending, Cards & Payments Business – Issuing & Acquiring)

· Optional strong understanding of domain - Core Banking, Retail Banking, Corporate Banking.

· Managed end-to-end project or test management in multiple engagements environment.

· Demonstrate good working attitude & leadership qualities.

· Strong interpersonal, communication skills and ability to work under pressure and tight deadline.

We regret to inform that only shortlisted candidates will be notified / contacted.

For more information you can email Leah Kanagaratnam in our Singapore office on leah.kanagaratnam@teksystems.com quoting Job Reference Leah Kanagaratnam 541420.

Job Reference: Leah Kanagaratnam 541420

EA Registration No: Leah Kanagaratnam, R22104472

Allegis Group Singapore Pte Ltd, Company Reg No. 200909448N, EA License No. 10C4544

Be part of shaping the Gold Coasts future!
The Gold Coast is inspired by lifestyle and driven by opportunity. We are the second largest Council in Australia.
As a 5-star employer of choice, we care about being the most flexible government organisation in Australia. We have a range of benefits to help you create the right balance: 

9-day fortnight
Flexible work arrangements to suit your lifestyle, including hybrid/work from home options, flexible working hours and locations. 
Personal and professional development courses
Access to 350 fitness facilities through Fitness Passport / Low cost on-site gym membership
4 free confidential counselling sessions a year for you or an immediate family member
1 free nutritionist and financial advice session per year

We pride ourselves on our shared mission of being a high-performing, customer-focused organisation which delivers value-for-money services to the
... Click here to view more detail / apply for Development Compliance Officer

RESPONSIBILITIES / ACCOUNTABILITIES:

• Develop, design and integrate software and hardware to achieve ATE test.
• Lead and/or participate in cross-functional teams to support engineering test projects
• Document test system and software designs
• Implement test plans, procedures, and generate reports
• Support design verification testing
• Support existing macros and scripts in Visual Basic or Python
• Any other duties the Employee may be instructed to carry out by the company from time to time that are reasonably within the scope of the Employee’s job position and work capabilities
• Work with multi-functional team to meet new product release schedule

REQUIREMENTS:

• Masters/bachelor’s degree in Electrical or Electronics / Communication Engineering with at least 5 - 10 years' experience in Test Development for semiconductors
• Stronghold in circuit analysis, system engineering, technical writing and test software coding
• Strong technical ability and knowledge of test instrumentation devices such as signal generators, oscilloscopes, spectrum analyzers and power meters
• Advanced understanding of statistical data analysis, design margin principles, analog and digital measurement techniques, schematic capture skills and manufacturing processes
• Knowhow in serial communication protocols and hardware – CAN, SPI, Ethernet, HDMI, USB
• Experience with LabVIEW, C++, VB, python, GIT, JIRA will be a strong plus
• Experience with Analog device, PMIC, PAC, power device testing will be a strong plus
• Experience with ETS-88, ETS-364, ETS-800 tester platform
• Experience in a manufacturing test engineering position in a high-volume manufacturing environment will be an advantage
• Candidates will be required to travel 15 – 20% of the time and may be required to work in different time zones

Please apply via our corporate website under the requisition number 7325 at http://www.qorvo.com/careers/ with a copy of your detailed resume. ​

- Must have market risk, capital markets or vendor background (trading / risk application) to be considered (eg, murex, calypso) – Any considered

- Sydney based

- Permanent position





The FRTB program encompasses both the reimplementation of the Bank's market data system for Basel 2.5 as well as the implementation of a new market data system of both FRTB SA and FRTB IMA.






Responsibilities:

The candidate will be responsible for the test management of the Basel 2.5 market risk engine implementation at the beginning and later on of the FRTB implementation.

This includes:

• Leading, guiding and monitoring the analysis, design, implementation and execution of the test cases, test procedures and test suites.

• Supervising the configuration management of test environments

• Scheduling tests for execution and then monitoring, measuring, controlling, and reporting on the test progress, the product quality status and the test results

• Adapting test plans and compensating as needed to adjust to evolving conditions.

• Writing summary reports on test status.

• Implementing testing process excellence & expertise across our application portfolio

• Engaging with external teams on test requirements, planning and cases

• Deploying and managing resources for testing.

• Managing testing results by coaching, counselling, and providing constructive feedback.

• Implementing automated business regression testing capability

• Upskilling business knowledge in the testing team and ensuring this knowledge is applied in impact/risk assessments and test cases.

• Applying a risk-based approach to testing processes and assuring there is no degradation in our application SLA's.

• Introduce & link data controls, especially to regulatory Critical Data Elements (CDE's)



Mandatory Skills Description:

Must have market risk, capital markets or vendor background (trading / risk application) to be considered (eg, murex, calypso)

• 8+ years' relevant experience in a similar role

• Experience writing test plans and test cases in the database and data analytics spaces.

• Project delivery experience

• Hands-on SQL skills with exposure to complex joins.

• experience of integration, functional, non-functional & user acceptance testing

• Excellent presentation and planning skills - Should be familiar with Microsoft tools like PPT, Visio etc.

• Experience with MS Word, Excel, Project Management and Analytics software

• Experience working in Agile / Scrum teams

• Previous exposure to scheduling tools

• Understanding of how relational databases operate



Nice-to-Have Skills:

• Strong attention to detail.

• Driven to deliver - proven ability to deliver the best possible results for the organisation; and shows determination, resourcefulness and a sense of purpose in achieving this

Senior Development Compliance Officer

The City is seeking an enthusiastic and motivated individual to fill the Senior Development Compliance Officer position in the City?s Compliance team. 

Salary from $97,901.81 to $103,198.77 per annum, depending on qualifications and experience ( up to 15.5% employer superannuation contributions)
Permanent ? full time position
5 weeks annual leave
Restricted private use or commuting use of council vehicle

City of Vincent is a vibrant and progressive inner-city local government, a place where you can make a real difference! We are proud to say that our passion and our purpose is to create an amazing place for current and future generations to enjoy. A place that residents are proud to call home, where businesses thrive and where people want to visit.
We want to be known for being a courageous, clever, and creative organisation where

... Click here to view more detail / apply for Senior Development Compliance Officer

Reference Number: S100-24-2863 Closing Date: 06-05-2024 Employment Type: Permanent Full Time Development Compliance Officers Multiple positions available – permanent full time (35hrs/week) Attractive salary starting from $1,682.08 per week 11% superannuation A fully maintained vehicle under Council’s leaseback vehicle policy About us: We are not your usual, we are upbeat, resourceful and determined. Our staff and community are at the core of what we do, looking for ways to work together and support each other. Naturally welcoming, we share good-natured humour and positivity. We aim to inspire a sense of possibility and create opportunities for all by rolling up our sleeves. Our workplace is agile and flexible, keeping ahead of the times. Be a part of it; let’s get something started.  Campbelltown City Council is an ambitious and innovative organisation in a rapidly growing city that is ideally located with easy access to key public transport and road links. Boasting extensive bushland areas along the…

Click here to view more detail / apply for Development Compliance Officers

For full details of the responsibilities and duties of this role please see the attached job description.

Responsibilities:

We are looking for compliance personnel to assist in enhancing the compliance risk framework of the company. The candidate will help to manage and execute the compliance programs, provide policy guidance and to carry out compliance training for the company’s diversified investment business groups. Depending on the candidate’s experience, duties will include the following:

• Conduct compliance reviews and monitoring/surveillance across the company’s business activities;

• Develop risk-based compliance programs to facilitate the execution of compliance reviews and monitoring;

• Advise the business units in meeting regulatory requirements through implementing appropriate compliance risk policies, assisting with the design and implementation of risk and compliance management initiatives, and enhancing and improving internal processes and procedures;

• Review the completed risk and compliance assessment returns from each area of the business, identifying trends and areas of concern and working with the business units to reduce any unacceptable exposures to regulatory risk;

• Provide compliance training and support through issuing of internal compliance updates, training modules and compliance guidelines

Requirements:

• Minimum 3-5 years’ relevant experience in compliance, audit or risk management in the securities, financial advisory or fund management industry

• Should have knowledge of key applicable regulations in Singapore such as the Securities & Futures Act, Financial Advisers Act, MAS Notices and Guidelines, AML/CFT regulations

• Excellent writing and communication skills

• Good interpersonal, influencing and networking skills

• Team player

Responsibilities:

We are looking for compliance personnel to assist in enhancing the compliance risk framework of the company. The candidate will help to manage and execute the compliance programs, provide policy guidance and to carry out compliance training for the company’s diversified investment business groups. Depending on the candidate’s experience, duties will include the following:

• Conduct compliance reviews and monitoring/surveillance across the company’s business activities;

• Develop risk-based compliance programs to facilitate the execution of compliance reviews and monitoring;

• Advise the business units in meeting regulatory requirements through implementing appropriate compliance risk policies, assisting with the design and implementation of risk and compliance management initiatives, and enhancing and improving internal processes and procedures;

• Review the completed risk and compliance assessment returns from each area of the business, identifying trends and areas of concern and working with the business units to reduce any unacceptable exposures to regulatory risk;

• Provide compliance training and support through issuing of internal compliance updates, training modules and compliance guidelines

Requirements:

• Minimum 3-5 years’ relevant experience in compliance, audit or risk management in the securities, financial advisory or fund management industry

• Should have knowledge of key applicable regulations in Singapore such as the Securities & Futures Act, Financial Advisers Act, MAS Notices and Guidelines, AML/CFT regulations

• Excellent writing and communication skills

• Good interpersonal, influencing and networking skills

• Team player

Responsibilities

• Develop and implement quality control processes and procedures for trackworkand railway projects.
• Conduct inspections and tests on trackwork components and railway systems to ensure compliance with quality standards.
• Monitor and analyze quality data to identify trends and areas for improvement.
• Collaborate with cross-functional teams to resolve quality issues and implement corrective actions.Manage and maintain the company's quality management system for trackwork and railway projects.
• Develop and deliver training programs on quality control and assurance specific to trackwork and railway projects.
• Conduct internal audits to evaluate the effectiveness of quality systems.
• Support continuous improvement initiatives to enhance overall trackwork and railway quality and customer satisfaction.

Requirements

• Bachelor's Degree in any Mechanical/Electronic/Mechatronics Engineering
• Good understanding in ISO standard for ISO 9000, 14000, and1800
• Railway project experience is a plus.lus

Interested candidates who wish to apply for the advertised position, please click on the APPLY button below to send in your resume to julie@talenttradersg.com

EA License No: 13C6305

Reg. No.: R1981808

For candidate who applied for the advertised position is deemed to have consented to us that we may collect, use or disclose your personal information for purpose in connection with the services provided by us.

Working days: 5 days work week
Working hours: 8.30am - 5.30pm
Location: Woodland

Foods Manufacturer

Responsibilities

• Overseeing the operation and whole function of QAQC department
• Establish, review and continuous improvement for Food Safety Management System (SFA Regulations / FSSC 22000 / HALAL / Customers’ requirement) and documentation.
• To lead the QAQC team towards managing, maintaining and food safety management system.
• Review and improve working procedure/criteria for manufacturing processes.
• Overseeing in export country registration, review of importing countries requirement and liaising with regulatory agencies.
• Assisting in laboratory set-up / Overview external lab testing Parameter
• Study the export /import, rule and regulation of the country
• Main point of contact for Government regulatory agencies and certification bodies.
• Any ad-hoc tasks assigned by superior

Chin Wai Loon Reg No: R24121618

The Supreme Hr Advisory Pte Ltd EA No: 14C7279

The Role:
My Client is a global fund manager and we are looking for a Compliance Manager for the Singapore office. This is a new headcount in the business with growth potential to take on a regional portfolio within the business. You will be given the autonomy to spearhead new Compliance polices and framework across the region.

Responsibilities:

• Oversee and spearhead the Compliance policies and processes across SG and HK.
• Provide Compliance and Business Advisory to global stakeholders
• Ensure that any new processes are in line with the MAS and HKMA
• Work with the global Compliance team and elevate the Compliance standards for the Asia business.
• Design Compliance training program and be the point of contact for any Compliance related issues in Asia.

Requirements:

• A bachelors degree in a reputable university
• 5 to 10 years of experience in a Compliance function – within Fund Management preferred
• CMS licensing application experience preferred
• Ability to liaise directly with MAS / HKMA
• Be able to work independently, while also being a strong team player

Take charge of this opportunity to welcome a new career challenge in 2024.

EA Personnel No R1985201
BeathChapman Pte Ltd
Licence No 16S8112

Working days: 5 days work week
Working hours: 8.30am - 5.30pm
Location: Woodland

Foods Manufacturer

Responsibilities

• Overseeing the operation and whole function of QAQC department
• Establish, review and continuous improvement for Food Safety Management System (SFA Regulations / FSSC 22000 / HALAL / Customers’ requirement) and documentation.
• To lead the QAQC team towards managing, maintaining and food safety management system.
• Review and improve working procedure/criteria for manufacturing processes.
• Overseeing in export country registration, review of importing countries requirement and liaising with regulatory agencies.
• Assisting in laboratory set-up / Overview external lab testing Parameter
• Study the export /import, rule and regulation of the country
• Main point of contact for Government regulatory agencies and certification bodies.
• Any ad-hoc tasks assigned by superior

https://wa.me/6596420989

WhatsApp: +65 9642 0989 (Han)

Email: supreme.cc.han@gmail.com

Chaw Chiaw Han, Reg No：R22106723

The Supreme HR Advisory Pte Ltd, EA No：14c7279