Regulatory Affairs Manager

Develop regulatory strategy and update the strategy based upon regulatory changes and business needs

Manage and execute regulatory compliance activities as required by the local regulations

Compile, prepare,reviewandsubmitregulatory submissions to the local health authorities as well as toidentifyissues early in the submission preparation process that couldimpactproduct launch

Monitor andsubmitapplicable reports and appropriate responses to the local health authorities

Review and manage the development, writing, implementation and maintenance ofappropriate procedures, templates, metrics, and databases related to regulatory activities and documentation in compliance with the local regulatory requirements

Interact with local health authorities during review process to ensuretimelyregulatory approval

Ensure compliance with product post marketing approval conditions

Manage product lifecycle maintenance such as product license renewal, listings, change control notifications, etc.

Complete all training asrequiredandmaintaintraining plans, records, etc.

Review product labeling for approval in advertising and promotional request, field communications, etc.in accordance withConvaTecstandards and procedures as well as the local regulations

Support and/orparticipateas necessary in quality compliance audits

Maintain the organization and security for all regulatory paper and electronic files

Provide support in product safety issues and product associated events and responsible for reporting to the local health authorities

Asappropriate, provide content for local labellingin accordance withlocal regulation and registration approval and work with relevant parties to release andmaintainthe local labelling

Prepare andsubmitall reporting activities associated with a removal or correction with the local health authorities andConvaTecGlobal Compliance Team

Maintaintimelyupdates of new product listing, product delisting, registration of new manufacturing sites, etc. into the relevant registration and listing databases. Support to commercial team in providing regulatory documents required for reimbursement and tender applications

Communicate regulatory issues that mayimpactthe marketing of the products to internal stakeholders

Work in close collaboration with key functions such as supply chain,marketingand countrybusiness unitmanagersfor regulatory project / change implementation

May be tasked to act as the company focal point for interaction with various government agencies in response to queries from the agencies

Bachelor/master's degree in science, MedicalTechnologyor related disciplines. Regulatory Affairs Certification (RAC) is preferred.

Minimum 5 years of experience in medical device regulatory affairs is necessary 

Related experience and knowledge in regulatory submissions to local authorityrequired

Related experience and knowledge in Quality Management System, including but not limited to recalls, correction and labeling requirements isadvantageous

Experience in Good Distribution Practice for Medical Devices (GDPMDS) requirements and ISO13485 isadvantageous

Industry memberships / Professional Registrations