Alcon Laboratories Malaysia Sdn Bhd Vacancies Senior Specialist, Safety Regulatory Operation

Alcon Laboratories Malaysia Sdn Bhd is looking for new potential candidates to fill in for Senior Specialist, Safety Regulatory Operation position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.

Job Description

Role Purpose

Submit regulatory reports (Initial, final and follow-up) to local health authorities for medical
devices. Coordinate with case processing as needed to ensure the report is complete, accurate
and on-time.

Major Accountabilities:

Manage day-to-day activities:
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
Participate in internal and external audits as subject matter expert
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
Recommend changes to improve practices and procedures.
Ensure all processes, policies and procedures are clearly defined, fully documented
Ensure all processes comply with Alcon standards and policies
Promote a strong and control environment and follow up on audit issues and implement
correcting measures
Education & Background:

Pharmacy / science graduate.
3 years of relevant experience with a Pharmaceutical or Medical Device Company
Excellent MS Office skills and SAP Receivables Management knowledge is an added
Knowledge of medical aspects of medical device safety, medical device vigilance in pre and
post-marketing safety practice
Languages - Korean & Mandarin

Company Overview

Alcon is the global leader in eye care. We offer the broadest portfolio of products to enhance sight and improve people’s lives. Our products touch the lives of more than 260 million people each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors, and there are millions more who are waiting for solutions to meet their eye care needs. Our purpose is reimagining eye care, and we do this through innovative products, partnerships with eye care professionals, and programs that enhance access to quality eye care.

Learn more at See Brilliantly.

How To Apply

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