Bsc Life science jobs at Siemens Healthcare Jobs – Life Science Regulatory Affairs Manager. Interested and eligible candidates can check out all of the details on the jobs details, jobs descriptions, eligibility, application procedure, and such given below
Job Title: Regulatory Affairs Manager
Location: Bangalore, India
Department: Quality Management
Id: 329187
Experience: 4-6yrs
Preferred Education: Medical degree or Bachelor’s degree in a life science or biomedical engineering discipline preferred. A strong knowledge of domestic and international regulations will be beneficial.
Job Responsibilities:
- 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 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
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