Preferred Education: Medical degree, or Bachelors’ degree in a life science or biomedical engineering discipline preferred. A strong knowledge of domestic and international regulations will be beneficial.
Ensure the medical device products comply with the regulations of the regions where it is planned to be marketed and sold.
Maintaining a good understanding of new and existing regulations, standards and guidances that may impact their organization’s products and processes.
Collect, collate and evaluate product specific information in order to create and update the dossiers that must be submitted for new product licenses and license renewals.
Prepare submissions for regulatory registration and renewals
Maintaining data and files on country registrations for future reference, particularly in the event of an audit by a regulatory agency
Preparing for and supporting internal, regulatory, and third-party audits as necessary
Collaborate with the project teams and explaining regulatory requirements, procedures, and policies to all employees and stakeholders as necessary.
Able to work in cross functional teams with good communication & interpersonal skills
Organization: Digital Industries
Company: Siemens Healthcare Private Limited
Experience Level: Experienced Professional
Full / Part time: Full-time