Position Summary

The person is responsible for preparation and maintenance of technical documentation and dossier and other regulatory related activities and being a RA representative at manufacturing site to drive and liaise with other worldwide team members to assess post market change notification impact assessment and support regulatory submission to external competent authorities. The person is also responsible for submission files preparation and maintenance for change notification approvals at the manufacturing site.

Responsibilities

• Responsible to maintain regulatory activities and its status at site level for product lifecycle and post market regulatory assessment for markets such as EU, US, to ensure compliance with all internal and external requirements, as well as supporting EU MDR certification activities
• Responsible for regional regulatory activities including product registration, change notification and license renewal for Australia and New Zealand
• Support in US FDA post-market reporting activities.
• Manage to meet project milestones through participating in development, implementing and maintaining regulatory strategies and regulatory submission plans together with worldwide/regional regulatory management teams
• Liaise with Regional Regulatory management team to prepare submissions according to relevant requirement.
• Review and approve documents to support Post Market Change notification such as Engineering Change Orders (inclusive of validation reports and Risk Management Reports), Design Change Notices, and labelling changes to reach compliance with international regulations and standards
• Represent RA team to participate, review, assess and approve or reject the non-conformance disposition proposals at manufacturing site
• Support internal and external audits as required
• Contribute and/or lead the review and improve regulatory processes when applicable.
• Maintain and file RA documentation and update relevant database, eg. Regulatory Assessment Tracker, Regulatory Assessment Meeting Minutes accordingly
• Any other duties as assigned

Requirements

• An University Degree or equivalent in sciences, medicine, pharmacy, engineering or another relevant discipline in the area of regulatory affairs or medical devices
• 1-3 years of experience in regulatory affairs and/or in quality management systems relating to medical device or pharmaceutical
• Knowledge of international regulations and standards for medical devices, mainly on European medical device regulation and U.S regulations
• Working knowledge and experience with competent authorities are an advantage
• Experience in ISO certification and audits in a medical device manufacturing environment preferred.
• Excellent communication skills to work with teams in multi-countries
• Must possess strong organizational, influencing, interpersonal and leadership skills with a "can-do" attitude
• Ease at explaining regulatory requirements to colleagues from other departments in different countries.
• Must be able to prioritize and handle several projects concurrently in a fast-paced and constantly changing environment
• Must be able to maintain confidentiality in dealing with regulatory and clinical documentation