Ansell is looking for a Senior Specialist Regulatory Compliance (Russia & CIS).
What your role will be:
Reporting to the EMEA/APAC Medical Regulatory Affairs Director, you will be:
Responsible for interactions with Russian Certification Centre’s, Testing Laboratories, Regulatory Authorities, Customs, Distributors and Consultants utilized.
Active member of the Russian medical / PPE federation, attend meetings and be the voice of Ansell during discussion on standardization and regulations.
Responsible for regulatory intelligence surveillance and communication to the relevant stakeholders of any upcoming changes.
Organizing plant audits as required by Regulatory Authorities and attendance at plant audits as per need.
Provide Regulatory Assessment and Advice on the go to market for Medical Devices / PPE in Russia and CIS.
Keeping up to date with national & international legislation, guidelines and customer practices in Russia and CIS in relation to Ansell Medical Devices / PPE.
Understanding and evaluating complex information; resolving registration or importation problems if they arise.
Playing an active role in the EMEA/APAC Regulatory Affairs team.
Provide assistance as required in dossier compilation and registration in the EMEA APAC region.
What you will bring:
Responsibility for Medical Device Dossier Compilation / PPE technical files in Russia and preferably of other countries within the CIS; Liaison with Regulatory Authorities.
Knowledge of Medical Device / PPE Regulations and Medical Device dossier / PPE technical files requirements in Russia and CIS.
Ability to liaise with a wide range of internal and external stakeholders and partners, work in Global Corporate environment.
Written and spoken English (upper-intermediate).
Ability to research and provide up to date Regulatory Intelligence for Russia and CIS.
Excellent Organisation, prioritization and communication skills.
Ability to work under pressure in the fast paced and changing environment.