Regulatory Affairs Executive

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...

Experience: 0 to 1 years of experience in Regulatory affairs. Qualification: B. Pharm / M. Pharm / MSc. Biotechnology Description: Regulatory Affairs Handling Dossiers License Queries CFT Communication Life cycle etc. *Immediate Joiners* Excellent in Communication Application Question(s): - Current CTC - Expected CTC - Notice...

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...

**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...

**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,...

Job Description: Regulatory Affairs Executive (ROW Markets) Industry: Pharmaceuticals Experience: 3-5 Years Loaction: Chennai Key Responsibilities: Dossier Submissions: Compile & submit ACTD, CTD, and country-specific dossiers for ROW markets. Regulatory Queries: Prepare and respond to health authority queries on submitted dossiers. Document Review: Review...

**Primary Responsibilities**: - **Regulatory Compliance**: Ensure that company products and processes comply with relevant regulations, such as FDA (21 CFR Part 820), ISO 13485, EU MDR, IEC 62304 ISO 20417, ISO 15223, ISO 10993-1 and other global standards. GSPR, Technical Documentation, Regulatory Gap Assessment. - Standard Operating Procedure (SOP) -...

**Job Title: Medical Device Regulatory Affairs Intern** **Overview** As a Medical Device Regulatory Affairs Intern, you will support managing the regulatory processes for medical devices. You will assist in preparing documentation, conducting research, and ensuring compliance with regulatory requirements. This internship provides a valuable opportunity to...

Full job descriptionThis role involves preparing, submitting, and managing regulatory documentation and applications to gain approval for products.Key Responsibilities:Prepare and submit regulatory applications to ensure timely approvals for new and existing products.Monitor and stay up-to-date on regulatory changes and requirements in different...