Product & Regulatory Manager

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Alcon
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November 04

Job Description

  • Lead the development, documentation, and implementation of regulatory strategies for new technologies and product modifications. Collaborate with R&D to determine and execute plans in support of regulatory submissions.
  • To lead and manage a team with approximate 200 associates (consisting of superintendents, engineer, supervisors, team/line leaders and inspectors) in performing batch record review/release ( for formulation, dry lens, optical tooling, finished product ) and in-process/final product testing/inspection and ensuring the operations are run efficiency and effectively with full compliance to Standard Operating Procedures (SOPs) and regulatory requirements.
  • Ensuring Pharmacopeial, ISO13485, Medical Device Single Audit Program (MDSAP), European Medical Device Regulation (EUMDR), United State Food and Drug Administration (FDA) and others country specific compliance and spearheading procedural harmonization across the units to make it in-line with corporate policies.
  • Management of Global Quality audit, external audit, Health Authority & regulatory audit, vendor audits and qualification programs.
  • Responsible for ensuring quality control plans are fully implemented.
  • Responsible for ensuring accurate and timely reporting of inspection/test data and trend charts.
  • Responsible for ensuring equipment are sufficient, calibrated and validated.
  • Responsible for ensuring staff are sufficiently trained and qualified to perform their jobs.
  • Responsible for ensuring staff comply to corporate quality standards and other corporate/site policies, rules and regulations.
  • Responsible for ensuring staff overtime meets company target and department expenditure is within budget.
  • Responsible for ensuring staff comply to data integrity requirements/policies.
  • Approval of change controls, deviations, investigations, instrument  qualifications, process validations, cleaning validations,  Manufacturing records, specifications, Analytical documents and standard operating procedures.
  • Ensuring compliance in the plant through regular internal audits and trainings.
  • Coordinate with customer and regulatory audits and ensure audits are smooth and well planned. Prepare and send response report.
  • Ensuring error free submission of documents required for regulatory filings and providing inputs for responding regulatory deficiencies.
  • Notification to the management on quality related issues.
  • Market compliant investigation and Recall handling.
  • Subject Matter expert - for analytical related issues.

Job Requirements

  • Minimum: Degree in Science or Bio-pharmaceuticals
  • Minimum: 10 years working experiences in medical device or pharma industry, prefer candidate with > 5 years management experiences
  • Well verse in Current Good Manufacturing Practices (cGMPs), United State Food and Drug Administration (FDA), ISO 13485, Medical Device Single Audit Program (MDSAP), European Medical Devices Directive (EUMDD) and European Medical Devices Regulation (EUMDR), and other applicable regulatory requirement.
  • Project management experiences.
  • Possess knowledge in validation and change request process
  • Possess good knowledge and hand on skills in data analysis, statistic and investigation skills.
  • Project management experiences.
  • Technical report writing and risk based approach assessment.
  • Regulatory Affairs assessment
  • Good leadership skills
  • Interpersonal and communication skills with ability to interact with local teams as well as Global teams.
  • Good presentation skills.
Skill & Language
Science or Bio-pharmaceuticals
4 - 6 years
N/A
1 candidate
December 06
Full Time
Management
Kepong, Kuala Lumpur
Alcon4 jobs · Kepong, Kuala Lumpur
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