Associate, Medical Device Safety Reporting
1 week ago
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 beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
Job Overview
Responsible for day-to-day regulatory reports submission (Initial, follow-up and final) to local health authorities for medical devices. Close coordination with internal case processing and supporting, as needed to ensure the report is complete, accurate and on-time submission.
Key Responsibilities:
- 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): China, Hong Kong, Taiwan
WHAT YOU’LL BRING TO ALCON:
- Minimum: graduation in science.- Ophthalmology/ Eye care experience desirable- Desirable: university degree in optometry/ pharmacy/ ophthalmology/ medicine/ pharmacology/ biomedical science/ biomedical engineering/ chemistry/ biology/ nursing or other healthcare discipline.- Fluent in both written and spoken English & Mandarin- 1-2 year of experience in pharmaceutical and medical device industries- Proven ability in implementing quality and documentation systems.- Record of accomplishment of tracking complaints- Effective communicator- Experience working within multinational pharma companies or medical device company desirable- Comprehensive understanding of national and international regulations for medical device vigilance and pharmacovigilance, medical terminology
HOW YOU CAN THRIVE AT ALCON:
- Opportunity to work with a leading global medical device company.- Collaborate with a diverse and talented team in a supportive work environment.- Competitive compensation package and comprehensive benefits.- Continuous learning and development opportunities.
Alcon Careers
ATTENTION: Current Alcon Employee/Contingent Worker
- Find Jobs for Employees
- Find Jobs for Contingent Worker
-
Associate, Safety Regulatory Operations
1 day ago
Selangor, Malaysia Alcon Full timeEnsure 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...
-
QA Complaint Handling Associate
1 week 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
1 week 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...
-
Logistics Manager
2 days ago
Subang Jaya, Selangor, Malaysia IDS Medical Systems Group Full time $90,000 - $120,000 per yearThe Manager I – Logistics will oversee the full spectrum of warehouse operations, including inbound, storage, inventory control, outbound, distribution and returns. This role requires strong management skills, regulatory awareness and hands-on operational capability to establish and maintain an efficient, compliant and customer-focused warehouse operation....
-
Medical Advisor, Patient Relations
2 days ago
Bandar Sunway, Selangor, Malaysia Sunway Medical Centre Sdn Bhd Full time 120,000 - 240,000 per yearJob PurposeServes as the hospital's central coordinator for all clinical-related complaints and grievances raised by patients and families.Ensures that every case is handled professionally, promptly, and with empathy, while safeguarding clinical integrity and supporting patient trust.As part of the hospital's Clinical Governance and Patient Safety framework,...
-
Medical Officer
3 days ago
Kuala Selangor, Malaysia MEDIDATA SDN. BHD. Full timeTo provide continuous primary & preventive healthcare, monitor and counsel on common illnesses, chronic management of diseases and medical/pre-employment screening for patients and Corporate Clients. To render evidenced based investigation to the patients. To participate the internal and external hospital events. To support business development,...
-
Safety Officer
2 weeks ago
Subang Jaya, Selangor, Malaysia MLDC Berhad (Malaysia Land Development Company) Full time 80,000 - 120,000 per yearResponsibilitiesManage and implement occupational safety and health policies to ensure compliance with laws and regulations. Stay up to date with changes in safety regulations and industry standards.Conduct daily site assessments to ensure all safety measures are executed in accordance with the project's safety plan. Perform routine checks to ensure that...
-
Resident Medical Officer
2 weeks ago
Kota Damansara, Selangor, Malaysia Sunway Medical Centre Damansara Full time 120,000 - 180,000 per yearSunway Medical Centre Damansara is HiringJob PurposeProvide consultation, management, treatment and deliver high-quality of patient care to maximize patient health outcomes.What is your role about?Deliver timely and appropriate care in urgent situations through patient assessment, stabilization, diagnosis, treatment, and referral, in line with the...
-
Medical Device Sales Representative
1 day ago
Subang Jaya, Selangor, Malaysia All Eights (M) Sdn Bhd Full time 80,000 - 120,000 per yearTHE JOB:To execute sales strategies and marketing plans to achieve the agencies' sales targetsTo effectively communicate and promote the clinical benefit and technical performance data of our diagnostics solutions to laboratory managers, scientific officers, HODs, clinical consultants, clinicians, and Key Opinion Leaders to develop/grow existing accounts and...
-
Medical Assistant
1 week ago
Kuala Selangor, Malaysia Selcare Clinic Sdn Bhd Full timeAssisting Medical Officer includes - Maintains safe and clean working environment by complying with procedures, rules, and regulations - Ensures operation of equipment by completing preventive maintenance requirements, calling for repairs and evaluating new equipment and techniques - Maintains clinic supplies & inventory Assisting Medical Officer...