Regulatory Submission Publisher

Purpose: Regulatory Submission Publisher will be responsible for assisting in the compilation, formatting, publishing, and validation of regulatory submissions in eCTD and non-eCTD formats. The role will provide exposure to global regulatory submission requirements for agencies such as US FDA, EMA, Health Canada, MHRA, and others.Responsibilities:• Assist...

Project Administration - Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions. - Provide basic regulatory affairs services...

Publishing Administrative Editor Would you enjoy providing editorial administrative support to a busy publishing team? Would you enjoy collaborating with teams to deliver a quality service to our journal community? About our Team Our team works with Editors, Authors, Reviewers and colleagues to manage the end-to-end editorial publication process. We...

**Job highlights** - Years of Experience: Minimum 5 Years in Medical Device/ Pharma/ Life science. Qualification: M Sc Life Science/ BTech Medical / B Pharm/ M Pharm. - Minimum of 2-3 years of experience in regulatory affairs Healthcare industry, with specific experience in USFDA / 510K submission and MDSAP Audit preparation **Job description** This is a...

Job Title Publishing Manager Company Srinivas Fine Arts Private Limited Location Chennai Job Type Full-Time Gender - Male or Female Age between 30 to 37 About Us Srinivas Fine Arts Private Limited is a leader in Printing and Book technology known for our innovative and high-quality products We are dedicated to pushing the boundaries of creativity and design...

General Accountability Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards. Assist in creation and maintenance of regulatory files. **Responsibilities**: 1. Write, analyze, and edit...

**Key Responsibilities**: - **Regulatory Compliance**: Ensure compliance with ISO 13485, EU MDR 2017/745, US-FDA, CDSCO, and other applicable international standards for medical devices. - **Submissions and Approvals**: Prepare, review, and submit regulatory documentation, including 510(k) and IMDR submissions, to regulatory authorities such as US-FDA,...

Full job description **Key Responsibilities**: - Monitor and stay up-to-date on regulatory changes and requirements in different regions. - Communicate with regulatory authorities and answer their queries or requests. - Ensure product labeling and packaging meet regulatory standards. - Maintain records of regulatory submissions, approvals, and...

Role - Regulatory Affairs - Medical Devices Experience - 1 to 3 Years Location- Madhavaram Chennai Budget - As per the industry Key Responsibilities 1 Regulatory Submissions Prepare and submit regulatory documents to authorities for approval such as new product applications amendments and supplements 2 Compliance Ensure products meet regulatory requirements...

Company Description GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective...