Regulatory Affairs Officer

**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...

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...

**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...

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...

**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...

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...

**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...

Summary:The Regulatory Affairs Officer ensures that pharmaceutical products comply with industry regulations. This role involves preparing and submitting regulatory documents, managing compliance, and maintaining product approvals.Roles and Responsibilities:Regulatory Submissions: Prepare and submit regulatory documents for product approvals and...

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...

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...

**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,...

KEY RESPONSIBILITIES:Regulatory Affairs:·Build the technical files and drive risk management.·Understand parts, processes and performance.·Implement engineering change management.·Perform regular IQA.·Work closely with all cross-functional team members.·Review design documents & participate in periodic design reviews.·A weekly operating mechanism on...

Reporting to: Assistant Manager – Regulatory Affairs Division: Ortho Implants Location: Chennai No. of Positions: 1 Education: B.E/ B. Tech in Biomedical Engineering / M. Pharm Regulatory Affairs Experience: 2 - 4 years Exp. in ‘scientific writing / clinical documentation’ role preferred KEY RESPONSIBILITIES: Technical writing, literature search,...

**Job Title:** Senior ExecutiveAt SUN PHARMA, we are seeking a highly skilled and experienced Senior Executive to join our team as a key member in the Plant Regulatory Affairs department.The successful candidate will be responsible for managing work related to Regulatory Affairs functions at Site. This includes monitoring for Documents compilation activities...

We are looking of a Regulatory Affairs Executive for a Manufacturing Company located in DeraBassi (Punjab) Currently opening is for Regulatory Affairs department. ISO 13485 will be preferable. Qualification: Diploma (Electronics / Electrical / Mechanical) Experience : 5 TO 7 years **Salary**: 40K To 45K Location: DeraBassi **Job Types**: Full-time,...

**Industry** Pharmaceuticals, Cosmetics, Medical Devices, Food Supplement, Labeling and Scientific Communications **Position** Full Time, Permanent **Division** Pubrica Brand **Reports to**: Pubrica Business Head **About Company** Guires Group is a renowned global provider of services in advanced Contract Research, Data Science, Development, Pilot...

Job DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at SUN PHARMA. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining strong relationships with external stakeholders.About the RoleThe Regulatory Affairs Manager will be responsible for:Monitoring and...