Regulatory Affairs Job Vacancies in Bhopal

Medical Device Regulatory Affairs Specialist

Fastdrive Consultancy

3 - 6 yrs
5.0 Lac/Yr
Bhopal

EU MDR ISO 13485 CDSCO Regulatory Compliance Quality Assurance and Control

Job Title:Medical Device Regulatory Affairs SpecialistBhopal LocationCompany: Intense Medical & Dental System Pvt Ltd Bhopal.Job Brief:We are looking for a skilled Regulatory Affairs Specialist to manage and coordinate regulatory compliance for our medical devices. This role requires strong communication with channel partners, collaboration with documentation teams, and ensuring all products meet regulatory standards for both domestic and international markets.______________Key Responsibilities:* Ensure medical devices comply with all applicable national and international regulatory requirements and standards* Prepare and submit regulatory submissions, including 510(k), PMA, and other global market registrations* Communicate with regulatory authorities (such as the FDA, CDSCO) to handle queries and support approval processes* Monitor and interpret changes in medical device regulations and assess their impact on the company* Provide regulatory guidance and training to cross-functional teams including R&D, QA/RA, and Product Development* Develop and implement regulatory strategies to support new product development and market expansion* Maintain organized, up-to-date documentation to demonstrate compliance and support audits* Collaborate with channel partners and internal documentation specialists to ensure consistent regulatory alignment______________Requirements:* Bachelors degree in Biomedical Engineering, or B.E electronic commination. or a related discipline* 34 years of experience in medical device regulatory affairs* Strong knowledge of domestic and international medical device regulations (FDA, EU MDR, ISO 13485, CDSCO, etc.)* Excellent verbal and written communication skills* High attention to detail, analytical thinking, and problem-solving ability* Experience working collaboratively across multiple teams______________Preferred Qualifications:* Regulatory Affairs Certification (RAC)* Experience with Class II or III medical devices* Familiarity with quality systems (e.g., ISO 13485, FDA QSR)Key Responsibilities: Quality Assurance and Control Regulatory Compliance Process Improvement Supplier Quality Management Key Documentation and Reporting

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Regulatory Affairs Executive

Intense Medical & Dental System Pvt. Ltd.

10 - 11 yrs
4.8 Lac/Yr
Bhopal

Software Quality Assurance Quality Assurance Executive

Key Responsibilities: Ensure medical devices comply with all applicable national and international regulatory requirements and standards Prepare and submit regulatory submissions, including 510(k), PMA, and other global market registrations Communicate with regulatory authorities (such as the FDA, CDSCO) to handle queries and support approval processes Monitor and interpret changes in medical device regulations and assess their impact on the company Provide regulatory guidance and training to cross-functional teams including R&D, QA/RA, and Product Development Develop and implement regulatory strategies to support new product development and market expansion Maintain organized, up-to-date documentation to demonstrate compliance and support audits Collaborate with channel partners and internal documentation specialists to ensure consistent regulatory alignment________________________________________Requirements: Bachelors degree in Biomedical Engineering, or B.E electronic commination. or a related discipline 3 - 4 years of experience in medical device regulatory affairs Strong knowledge of domestic and international medical device regulations (FDA, EU MDR, ISO 13485, CDSCO, etc.) Excellent verbal and written communication skills High attention to detail, analytical thinking, and problem-solving ability Experience working collaboratively across multiple tea

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Regulatory Affairs Job Vacancies in Bhopal

Medical Device Regulatory Affairs Specialist

Regulatory Affairs Executive

Apply to 2 Regulatory Affairs Job Vacancies in Bhopal