Regulatory Affairs Change Analyst

5 months ago


Kuala Lumpur, Malaysia BD Full time

**Job Description Summary**: This position supports execution of the Software CoE by understanding the infusion and dispensing systems as well as the Software Technology Services components which rely on these systems. Through this understanding and experience, accurate and thorough change assessments are completed and reviewed cross-functionally.

We are **the makers of possible**

BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

**Why Join Us?**

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a **maker of possible **with us

**_ Essential Responsibilities:_**
- Create and perform ongoing assessment of software tools and relative to the parent device or module.
- Collaborate with cross functional team to understand changes to effectively assess changes within the component under analysis and the system itself.
- Ability to work under pressure on multiple smaller and larger projects concurrently.
- Experience in regulated environment.
- Experience with software design, architecture, verification.
- Communicate progress and milestones for project initiatives.

**_ Qualifications_**
- BA/BS required
- Proficient in English
- Highly strategic and analytical problem solver with solid business acumen.
- Ability to prioritize and execute a variety of objectives and clearly communicate progress and roadblocks
- Ability to articulate complex concepts, thought leadership and the business value of solutions in a clear, understandable way

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

**Primary Work Location**: MYS Kuala Lumpur - Jalan Kerinchi

**Additional Locations**:
**Work Shift**:



  • Kuala Lumpur, Malaysia Medtronic Full time

    **Careers That Change Lives **We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Quality & Regulatory Affairs and help shape policies that change lives. Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and...


  • Kuala Lumpur, Malaysia Zoll Medical Corporation Full time

    **Regulatory Affairs Specialist**: **Location: Remote, Remote**: **Circulation**: At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients...


  • Kuala Lumpur, Malaysia BI (Malaysia) Sdn. Bhd Full time

    **The Position**: - To achieve timely & successful product registrations in accordance with corporate & local strategies. - To update the Company on new Regulations and Guidelines, and to ensure the Company complies with the local legislations & industry codes governing the import and control of therapeutic products. - To ensure compliance with Company...


  • Kuala Lumpur, Malaysia ZOLL LifeVest Full time

    **Location: Remote, Remote**: **Circulation**: At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary...

  • Quality Assurance

    5 months ago


    Kuala Lumpur, Malaysia Recruit Express Full time

    **Principal Function** As a Quality Assurance (QA) and Regulatory Affairs (RA) Executive, you will play a key role in ensuring compliance with relevant regulatory requirements and maintaining the highest standards of quality across our organization. You will collaborate closely with cross-functional teams to implement and maintain quality management systems...


  • Kuala Lumpur, Malaysia DKSH Full time

    **Location**:Kuala Lumpur, MY, MY**Job Summary** Supervise the execution of company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and regulations **General Responsibilities** - Support superior in managing day-to-day operating...


  • Kuala Lumpur, Malaysia Novonesis Full time

    **Location**: Malaysia : Kuala Lumpur **Country**: Malaysia**Our purpose points the way** In Novonesis, we know that solutions rooted in biology can help solve humanity’s biggest challenges. Since we began more than a century ago, this has been our guide. It’s how we've gotten so far. And it’s how we'll impact the future. Now, more than ever, the world...


  • Kuala Lumpur, Malaysia NuFarm Full time

    Regulatory Affair Executive/ Manager Support Registration of Few Countries in SOUTHEAST Asia Grow a Better Tomorrow with Nufarm. Nufarm is the dependable partner behind thousands of agricultural success stories. Every day, growers around the world turn to our products and our people to help with the challenges of fighting disease, weeds, and pests, and...


  • Kuala Lumpur, Malaysia Agensi Pekerjaan Permit Pro Consultancy Sdn Bhd Full time

    **Job Summary**: As a Junior Regulatory Affairs, Quality Assurance & Compliance Executive, you will play a crucial role in supporting regulatory processes, ensuring compliance, and maintaining product quality within the specified regions of Malaysia, Philippines, Vietnam, Singapore, Cambodia, Laos, and Myanmar. This role involves assisting with product...


  • Kuala Lumpur, Malaysia Organon Full time

    **Responsibilities**: The Specialist is responsible for all PV and RA submission requirements and PV activities for their assigned product portfolio as applicable (medical device and pharmaceutical products. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting...

  • Quality Assurance

    5 months ago


    Kuala Lumpur, Malaysia Recruit Express Service Sdn Bhd Full time

    **Principal Function** As a Quality Assurance (QA) and Regulatory Affairs (RA) Executive, you will play a key role in ensuring compliance with relevant regulatory requirements and maintaining the highest standards of quality across our organization. You will collaborate closely with cross-functional teams to implement and maintain quality management systems...


  • Kuala Lumpur, Malaysia Pfizer Full time

    The Regulatory Affairs Protege for GRS IRSP-Asia is responsible for assisting GRS-RSPI Asia in the preparation and submission of registration documents to Regulatory Authority and other administrative tasks. - Administrative Duties: Handle ad-hoc administrative tasks Records and documentation maintenance (filing, photostating, store maintenance, dispatch...


  • Kuala Lumpur, Malaysia iNova Pharmaceuticals Full time

    **iNova was certified as a Best Place to Work in 2021. We are innovative, motivated, and passionately solution focused to support our customers in leading a healthy lifestyle. Join the team to experience the reasons why people love working for us!** **The Opportunity** We currently have an opportunity for an experienced Regulatory Affairs Associate,...


  • Kuala Lumpur, Malaysia The Estée Lauder Companies Full time

    The Regulatory Affairs Executive is responsible for ensuring that our products meet all legislative requirements. Key duties of the job include studying scientific and legal documents, gathering, evaluating, organising, managing and collating information in a variety of formats. **What You Will Achieve** - **Ensures Compliance**:Ensures all products meet...


  • Kuala Lumpur, Malaysia BD Full time

    **Job Description Summary**: Reporting to the Associate Director of Regulatory Operations, the Data Analyst will analyze, review, chart, collect and enter global UDI attributes and global labeling information into predefined systems, such as Product Information Management (PIM) database. This position is responsible for supporting implementation and...


  • Kuala Lumpur, Malaysia BD Full time

    **Job Description Summary**: We are **the makers of possible** BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech...


  • Kuala Lumpur, Malaysia BD Full time

    **Job Description Summary**: We are **the makers of possible** BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech...


  • Kuala Lumpur, Malaysia BD Full time

    We are **the makers of possible** BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the...

  • Business Analyst

    5 months ago


    Kuala Lumpur, Malaysia HSBC Full time

    -Job description **Why join us?** The Finance Change Delivery team supports transformation activities on Finance systems used by HSBC. This role works proactively with multiple stakeholders, including end users of Finance systems and technical teams to develop effective and efficient regulatory reporting platforms and processes. The role holder shall be...


  • Kuala Lumpur, Malaysia Recruit Express Service Sdn Bhd Full time

    **Key Responsibilities** - Implement quality assurance policies and procedures to ensure compliance with applicable regulations and standards. - Support all aspects of the Quality Management System including updating QMS manuals, SOPs and forms, conducting internal audits, and follow-ups on NC/CAPA. - Investigate and resolve quality issues, including...