Regulatory Affairs jobs in Malaysia

Teleflex is a global provider of medical technologies focused on improving health and quality of life. Teleflex offers a diverse portfolio across anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. Teleflex is home to brands including Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck.

Global Operations is a complex organization responsible for end-to-end product fulfillment. We focus on improving quality, service, and value for customers and are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic team delivering medical technology solutions that make a difference in patients’ lives.

• Successful completion of the Program on schedule and on budget.
• Management of the program plan including scope, schedule, cost, technical, resource and risk management.
• Establish and maintain detailed technical plans, estimates and schedules.
• Program tracking and reporting (cost, schedule, and milestone accomplishments) using project scheduling, reporting and financial management tools as appropriate.
• Ensure the following deliverables are achieved as per Teleflex procedure TG-000080.
• Identify risks and develop mitigation plans, and communicate these to the Program Director.
• Ensure implementation and maintenance within the department of effective management for occupational safety and health consistent with the Occupational Safety and Health Act 1994 and other legislative requirements.
• Ensure the Program conforms to the Quality System Regulation (QSR), CMDCAS, MDD93/42/EEC, MDR, ISO 13485 and other relevant standards.
• Lean the manufacturing process for all products involved in the program.
• Oversee all technical aspects (equipment, facilities, etc.) of the project and ensure products are analyzed against appropriate standards using suitable techniques and documentation. Sterility Assurance involvement is required during the design/development phase for new cleanroom transfers.
• Manage all equipment that requires calibration, ensuring it is carried out and maintained.
• Develop detailed process maps, identify key performance criteria, quality attributes and equipment, etc.
• Create a Transfer Validation Plan (TVP) defining the validation work statement for the transfer.
• Update the Sending and Receiving Site Validation Master Plans to reflect transfer activities.
• Perform technical assessment and screening of the product/process against current manufactured product and/or Product Performance Specifications or equivalent documentation (e.g., DHF, DMR).
• Conduct engineering studies for key product outputs.
• Establish process input-to-output relationships prior to move and validation if identified by the teams.
• If SPC is not deployed, consider collecting SPC data to support the receiving site’s Quality Control Plan; not mandatory but suggested for critical processes not under SPC.
• Identify special processes requiring validation or verification.
• Review, revise, or generate documentation on equipment, tooling, specifications, drawings, etc.
• Collaborate with Quality on validation of equipment and processes.
• Review PFMEA and update as needed.
• Work with Technical Engineer, Process Engineers and Quality Engineer to execute validation protocols for facility validation, equipment validations, operation qualification validation and process qualification validations.
• Ensure in-process inspection and testing equipment is in place and meets testing requirements.
• Review history for customer complaints and non-conformances such as NCR, SCAR, CAPA, Recall, EIF for all products involved in the program.

Qualification: Minimum education bachelor’s degree in a technical field (Engineering or Science).

Experience: At least 10 years’ experience in manufacturing / engineering environment.

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.

Teleflex is an equal opportunities employer.

Teleflex does not accept unsolicited resumes from agency recruiters or 3rd party firms and does not make unsolicited job offers. Teleflex does not ask for money or require equipment purchase up-front.