Associate, Safety Regulatory Operations
7 months ago
Ensure the required regulatory reports are submitted complete and on-time
- Follow-up as needed with internal functions and regulatory agencies, to gather missing/required information to ensure compliance to requirements
- Perform investigation for any late reporting, determine root-cause and implement required actions
- Own the process, drive improvements to gain efficiency and effectiveness
- Track required metrics to for process oversight and escalate any issues
- Subject matter expert on local regulations and requirements to support Alcon portfolio of products
- Exercise judgment within defined procedures and practices to determine appropriate action
- Recommend changes to improve practices and procedures.
- Support, collaborate and ensure Country inspection readiness (internal and/or external). Support for and close out of audits, corrective plan, investigation, related to regulatory report. Proactive identify compliance issues and compliance gaps, follow up and closure of observations in close cooperation with regional and global.
- Ensure all processes, policies and procedures are clearly defined, fully documented
- Ensure all processes comply with Alcon standards and policies
- Responsible country(ies): South Korea
Key Performance Indicators (KPI)
Prepare high quality regulatory reports for submission on or before assigned due dates
Close collaboration with Alcon’s country patient safety lead and/or quality manager and/or regulatory manager in preparation and submission of regulatory inquiry
No critical findings in audits or inspections
Associate is authorized:
To submit product adverse event reports to the country Health Authority (HA) within timeline, leverage into the Quality Summary prepared by the Global Device Vigilance (GDV)
To coordinate with the GDV colleagues for advice and clarification of any received Alcon's prepared responses, prior official submission
To translate Alcon's response into local country language, and seek for country approval (when applicable) prior HA submission
To coordinate with Alcon's Regaff team into the response to HA's inquiry within timelines
**Education**:
- Tertiary qualification in optometry/ pharmacy/ ophthalmology/ medicine/ pharmacology/ biomedical science/ biomedical engineering/ chemistry/ biology/ nursing or other healthcare discipline.
Languages:
- Fluent in English and Bahasa Malaysia (spoken and written)
- Fluent in Korean (spoken and written)
Key Competencies/Behaviours:
- Technically Competent.
- Results Driven
- Customer / Quality Focus
- Empowerment / Accountability
- Mutual Respect / Trust / Loyalty
**Experience**:
- 1- 2 years of experience in pharmaceutical/chemical and medical device industries
- Proven ability in implementing quality and documentation systems.
- Record of accomplishment of tracking complaints
- Effective communicator
-
Regulatory Affairs Specialist
7 months ago
Selangor, Malaysia Alcon Full timeRegulatory Affairs Specialist (Mandarin Speaker) At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and...
-
Regulatory Affairs Executive
8 months ago
Selangor, Malaysia Almedico Sdn Bhd Full time**Purpose** - To ensure that all product registrations are approved and ensuring the maintenance of these approvals by Medical Device Authority Malaysia. - To respond efficiently for all field safety corrective action (FSCA) and product complaints / recall-related issues. - To be in charge of maintaining the Goods Distributor Practices of Medical Devices...
-
Safety Officer
7 months ago
Selangor, Malaysia Pasona Malaysia Full time**Job ID** **22368** **Position Title** - Safety Officer **Industry** - Manufacturing/Production - ・Responsible for safety, health and environment systems, procedures and provide policies on occupational safety & health for the company. - ・To liaise with local authorities and government agencies on statutory/legislature compliance matters concerning...
-
Associate, Medical Device Safety Reporting
7 months ago
Selangor, Malaysia Alcon Full timeAt Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...
-
New Product Development Executive
9 months ago
Selangor, Malaysia F&B Nutrition Sdn. Bhd. Full timeIdentifying market opportunities and associated new product strategies. - Developing new product value propositions and targeted feature sets. - Developing commercial/pricing strategies (e.g - low price or high quality). - Ensuring new product success through close collaboration with research and design, manufacturing, marketing, and sales leadership. -...
-
Quality Manager
7 months ago
Selangor, Malaysia Eaton Full time**What you’ll do**: This position is responsible for leading the development, execution and deployment of the Quality Management System of Eaton-SIAEC JV in Malaysia in conjunction with plant leadership. Provides Total Quality Leadership to customers, suppliers, partners and internal manufacturing cells. Leads continuous improvement activities in targeted...
-
Factory Operator
7 months ago
Hulu Selangor, Malaysia WE CARE INDUSTRIES SDN BHD Full time**Key Responsibilities**: - **Operations Management**: Oversee the daily operations of the factory to ensure efficiency and effectiveness. Develop and implement operational policies and procedures. - **Team Leadership**: Lead, supervise, and motivate factory staff. Handle hiring, training, and performance evaluations. - **Inventory Control**: Monitor and...
-
Associate Principal, Partner
2 weeks ago
Selangor, Malaysia Hiredly X Full timeBuild and maintain strategic partnership with vendor. - Drive and lead regular tactical and operational forums with respective vendors to escalate and address day-to-day challenges. - Customer service oriented mindset and able to associate impact of operational problem to customer experience. - Responsible to drive vendors to deliver new means of measurement...
-
Associate Manager Corporate Communications
7 months ago
Selangor, Malaysia Philip Morris International Full timeWe are looking for an Associate Manager Corporate Communications who will be playing a pivotal role to execute and amplify PMM media strategy through communication, contribution and programmes to all levels of stakeholders including regulatory, external and internal stakeholders. This is a renewable contract position. You will be working with a team of...
-
Boiler Operator-licensed
4 days ago
Hulu Selangor, Malaysia Marriott Worldwide Full time**Responsibilities**: - Job Number **1 - Job Category Engineering & Facilities - Location Marriott Puerto Vallarta Resort & Spa, Paseo La Marina Norte 435, Marina Vallarta, Puerto Vallarta, Jalisco, Mexico VIEW ON MAP - Schedule Full-Time - Located Remotely? N - Relocation? N - Position Type Non-Management- Monitor and inspect boiler equipment, computer...
-
Investment Operations Associate
7 months ago
Selangor, Malaysia Iterative Full time**About Iterative**: Iterative is an accelerator that invests exclusively in startups in Southeast Asia. Founded in March 2020 by Hsu Ken Ooi and Brian Ma, Iterative has raised $65M across 2 funds, invested in 65+ companies, 120+ founders and the total value of Iterative companies is now worth $1.2 billion. Our investors include Cendana, K5 Global, Village...
-
Operator
7 months ago
Kuala Selangor, Malaysia OPTIMAL NUTRITION SDN BHD Full timeOperator - Responsible for carrying out all manufacturing operations such as preparation of raw materials, packaging materials, packing of finished goods and transportation of finished goods. - Strictly adhere to GMP, food safety, NPRA regulations and workplace safety policies. - Ensure that goods produced are of the highest quality. - Prepare, operate and...
-
Js Association Manager Infrastructure
7 months ago
Selangor, Malaysia Pasona Malaysia Full time**Job ID** **22841** **Position Title** - JS Association Manager Infrastructure **Industry** - Call Center/BPO/Shared Service - Knowledge and experience of managing Cloud Infrastructure (Public and Hybrid Cloud) - Knowledge and experience of managing Operating system (VMWare, Linux and Windows) - Knowledge and experience to maintain existing scripting...
-
People Operations Associate
2 weeks ago
Selangor, Malaysia Food Market Hub Full timeOnboarding: - Issue Employment Agreements - HRIS setup - Laptop set-up for new hires in KL - Issue asset letter - EPF and SOCSO registration for new hires + submit Form CP22 - Door Access for KL office - Employment journey: - HRIS admin (role change, transfers, promotions, salary adjustments) - Leave management: thru HRIS and Slack channel - Employee...
-
Warehouse Associate
7 months ago
Kuala Selangor, Malaysia Makmur Jaya Full time**[FULL-TIME PERMANENT CONTRACT SHOPEE]** Location**:Pulau Indah,Port Klang** (Target Advertisement: Port Klang/Pelabuhan Klang *Peluang anda bekerja di Syarikat E-Commerce Terkenal di Malaysia!* - **Position: Warehouse Associate/Warehouse Operator & Assistant or Materials Handler**: - **Jawatan:Warehouse Associate/Warehouse Operator & Assistant or...
-
Operator
5 days ago
Hulu Selangor, Malaysia MLFD GROUP SDN BHD Full timeperforming routine maintenance checks, following strict safety regulations and guidelines and operating mechanical or computer-operated equipment. Manufacture of ID Door and Fire Rated Door SPM / O Level / SKM Level 1 / SKM Level 2 / SKM Level 3 or Equivalent
-
Document Scanning Operator
7 months ago
Selangor, Malaysia Konica Minolta Business Solutions (M) Sdn. Bhd. Full time**Responsibilities**: - To Operate with imaging tools for use in the creation of electronic files or archives. - Prepare, scan, and perform quality checking of documents/images being converted to - electronic/digital format and ensure the outputs are properly transferred and indexing of images. - To clean and perform basic maintenance on scanning equipment....
-
Assoc. Dir. Ddit Apd Shared Services
7 months ago
Selangor, Malaysia Novartis Full time**Summary**: About this role: The Associate Director will play a relevant role and will have an impact on multiple Novartis DDIT (DATA, DIGITAL & IT) ERP projects and beyond, which will greatly contribute to the success of many business/organization Goals. The Associate Director will be responsible for the definition processes, methods and tools for a...
-
QA Complaint Handling Associate
7 months ago
Selangor, Malaysia Alcon Full timeAt Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...
-
QA Complaint Handling Associate
7 months ago
Selangor, Malaysia Alcon Full timeAt Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...