Regulatory Affairs Specialist (RTG/Structural Heart)

Job duties: Obtains timely regulatory approvals to meet business objectives.Prepares and coordinates regulatory/registration submissions.Ensures that submissions meet relevant external and internal requirements.Ensures documentation used, questions and answers from authorities and approvals are filed in the appropriate systems.When/ where applicable, supports distributors to obtain the necessary regulatory approvals.Coordinates the execution of Field Corrective Actions.Provides support for vigilance reporting to the regulatory authorities.Coordinates translation of product labeling (IFU and Label) if applicable.Maintains internal databases for regulatory compliance (eg Famous and RAD).Develops proficiency in any applicable regulatory requirement that applies to our products and ensures new or changed requirements are communicated within the organization.Provides support to tender offers in case of necessary regulatory documentation.Requirements: Msc degreeBsc degree with relevant experienceTechnicalProven track record of relevant regulatory environmentExperience working with Government officialsProven track record of experience working with complex databasesExperience working as a self-starterExperience with device safety reportingExperience in Quality SystemsWork experience working with distributorsWork experience within large enterprisesWork experience in supply chainProficient in English, both written and spoken

View the original article here

Posted by Anthony Chuks at Wednesday, January 28, 2015

Email ThisBlogThis!Share to XShare to FacebookShare to Pinterest

Labels: Affairs, Heart, Regulatory, RTGStructural, specialist