Associate, Safety Regulatory Operations

5 months ago

Selangor, Malaysia Alcon Full time

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

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