Quality Assurance Regulatory Affairs Manager- Equipments

**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 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...

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...

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 2 years’ progressive Regulatory affairs experience in medical device & quality...

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...

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...

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...

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...

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...

**Hi ,** **Urgent opening for Regulatory affairs -Executive** **Hiring **:Regulatory affairs -Executive **Location: - Chennai / Dehradun** **Experience: - 5+Years** **Notice Period: - 0-15 Days** **Industry : Pharma** **Qualification : M Pharma / B Pharma** ( **Knowledge of ROW, Emerging market, ZAZIBONA and EU market requirements and ICH guidelines...

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...

**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...

**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 correspondence. - Support product...

**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,...

We are looking for Quality Assurance in Healthcare Department, About us: Shield is founded in 1995. One of the respected Pharma companies in India under Gynecology segment. Shield portfolio offers a wide range of brands supported by scientific findings from clinical trials and research studies. We are in the field of Women’s Healthcare. About the...

We are looking for Pharmaceutical Industry in Production OR Quality Assurance About the role: A specialist in quality assurance with insight into quality systems, risk analysis, conflict management, and customer care. Possesses problem solving, interpersonal, and demonstrated leadership skills to build effective interactions with internal & external stake...

**Regulator Chemist** **Location**:Chennai, India **Required Language**:English **Employment Type**:Full-Time **Seniority** **Level**:Associate** **Travel** Mode**:Moderate ***: **About Us**: Buckman is a privately held, global specialty chemical company with headquarters in Memphis, TN, USA, committed to safeguarding the environment, maintaining...

The Regulatory Affairs Specialist will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA (United States Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) approvals for products manufactured at our plant. This role requires comprehensive knowledge of regulatory requirements,...

The Regulatory Affairs Specialist will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA (United States Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) approvals for products manufactured at our plant. This role requires comprehensive knowledge of regulatory requirements,...

As a Quality Manager you will be responsible for ensuring the company’s products meet all quality standards. Develop, implement, and maintain an ISO 13485-compliant Quality Management System. Work closely with all cross-functional team members & get the documentation ready for certifications and audits. Develop, review and approve the documents as per the...