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...

We are in the process of hiring Regulatory Affairs **Job Title**: Regulatory Affairs Executive **Key Responsibilities**: **Qualifications**: Bachelor Degree in a related field such as Biomedical engineering, Mechanical engineering with minimum of 5 to 7 years’ progressive Regulatory affairs experience in medical device & quality...

**Job description** We are looking for a motivated and experienced Regulatory Affairs Specialist to join our team! As a Regulatory Affairs Specialist, you will be responsible for the day-to-day monitoring of the company’s regulatory activities to ensure compliance with all regulations. You will be a key member of our regulatory affairs team, which is...

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice, is searching for an Executive - Regulatory Affairs (PLMDS) to join one of our clients. **Main Job Tasks and Responsibilities**: - Complete...

**Experience**: 1 to 2 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 **Job Types**: Full-time, Permanent Pay: Up to ₹28,000.00...

Job Summary The Regulatory Affairs Specialist is responsible for ensuring compliance with all applicable regulations governing the development, manufacturing, and distribution of the company's products. This role involves collaborating with internal teams and regulatory agencies to facilitate product registrations, approvals, and adherence to quality...

Job Description Role - Regulatory Affairs - Medical DevicesExperience - 1 to 3 YearsLocation- Madhavaram, ChennaiBudget - As per the industryKey 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...

**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: PharmaceuticalsExperience: 3-5 YearsLoaction: ChennaiKey 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 BMR,...

Regulatory Affairs SpecialistThis is a key role within our organization, responsible for ensuring compliance with regulatory requirements. The Regulatory Affairs Specialist will work closely with cross-functional teams to prepare and submit amendments and supplements for assigned products.Key Responsibilities:Amendment and Supplement Preparation: Prepare,...