Regulatory Affair Manager Futura Surgicare

10.0 - 20.0 years

10 - 20 Lacs

bengaluru

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Position Title: Regulatory Affairs & QA Manager Department: Quality & Regulatory Affairs Location: Bangalore Role Overview The Regulatory Affairs cum QA Manager will be responsible for ensuring compliance of medical devices with applicable international and local regulatory requirements, while also leading the Quality Management System (QMS) to meet ISO 13485, MDR, US FDA, and other relevant standards. This role is critical in bridging product development, regulatory submissions, audits, and market access, ensuring patient safety and product quality at all times. Key Responsibilities Regulatory Affairs: Develop and implement regulatory strategies for product registration, approvals, and certifications (CE marking, US FDA, CDSCO, etc.). Prepare, compile, and submit regulatory dossiers for global markets. Act as liaison with regulatory authorities, notified bodies, and certification agencies. Monitor changes in global regulatory requirements and assess impact on company products. Support product labeling, claims, and advertising compliance with regulations. Maintain regulatory databases, technical files, and Design Dossiers. Quality Assurance: Lead and maintain the companys Quality Management System (QMS) in line with ISO 13485, ISO 14971 (Risk Management), MDR, and FDA QSR (21 CFR Part 820) . Plan, conduct, and manage internal and external audits (regulatory, customer, notified body). Ensure effective CAPA (Corrective and Preventive Action) and complaint handling processes. Oversee supplier qualification, incoming inspection, and vendor audits. Ensure proper document control, change control, and training compliance. Drive continuous improvement in quality systems, manufacturing processes, and compliance culture. Cross-functional Support: Work closely with R&D and Manufacturing for design control, risk assessment, and regulatory compliance during product development. Support clinical evaluation, PMS (Post-Market Surveillance), and vigilance reporting. Provide training and regulatory/quality guidance to internal teams. Key Requirements Education: Bachelors / Masters degree Experience: Minimum 610 years in Regulatory Affairs and Quality Assurance in the medical device industry . Strong knowledge of ISO 13485, MDR 2017/745, IVDR, US FDA 21 CFR Part 820, ISO 14971, IEC 60601, and other relevant standards . Proven experience in regulatory submissions, audits, and product registrations . Excellent understanding of QMS implementation and maintenance . Strong analytical, documentation, and project management skills. Effective communication and leadership skills to work with cross-functional teams and external regulators. Kindly fill the below mentioned details Notice Period: Current Salary: Expected Salary: Current Address: Experience in USFDA: Experience in EU MdR: Experience in CDSO: Experience in Product Registration: Availability for a Google Meet interview Preferred Date: Preferred Time: Kindly share your update resume to Mithun@futura.limited or WhatsApp: 6366138846 .

Posted 22 hours ago

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Liasion trainee Biophore

0.0 - 2.0 years

2 - 3 Lacs

Hyderabad

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Roles and Responsibilities Assist in Liaise with government agencies such as State Drug Control Board, Food & Drug Administration (FDA), Central Drugs Standard Control Organization (CDSCO), and other relevant authorities. Ensure compliance with regulatory requirements related to drug licensing, manufacturing, and distribution. Develop strong relationships with key stakeholders including government officials, industry associations, and trade bodies. Provide technical support on pharmaceutical matters to internal teams and external partners.

Posted 2 months ago

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Liasioning Officer Biophore

3.0 - 6.0 years

2 - 5 Lacs

Hyderabad

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Roles and Responsibilities Liaise with government agencies, including State Drug Control Organization (SDCO), Excise Department, Police Department, and other stakeholders to obtain necessary licenses and permissions for the company's operations. Ensure compliance with relevant laws and regulations related to drug control, excise, and other relevant fields. Develop strong relationships with key officials at these organizations to facilitate smooth communication and collaboration. Provide guidance on regulatory requirements to internal teams and ensure that all activities are aligned with applicable laws and regulations. Monitor developments in government policies and initiatives affecting the industry.

Posted 2 months ago

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Compliance Specialist Samsiddhi Business Solutions

2.0 - 6.0 years

2 - 3 Lacs

New Delhi, Gurugram, Delhi / NCR

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We currently looking for Medical Device Affairs and Compliance Specialist for one of our entity Faith Innovations. please find the following Job Description. 1. Designation:- Compliance Specialist ( Male only ) Salary:- 25K -35K/PM Location:- Delhi Company:- Faith Innovations No. of positions 01 Educational Qualification: B. Tech (Electrical & Mechanical engineering) Experience: Mandatory: 2-3 yr in the medical devices QA/RA Drive completion of compliance requirements whenever assigned by the Compliance team and/ or Function head i.e., to update and review records and documents for completeness and compliance as per MDR and ISO requirements Ability to understand the classification of medical devices as per Medical Device Rules 2017 and assist in the preparation of technical files and medical device master files for regulatory submission. To understand and have knowledge on the implementation of the Risk Management File, Plan and Procedures as per ISO 14971. Reviewing and handling of the incidents received from the Notified body or Competent Authority and updating and reviewing SOPs for accuracy and completeness as applicable under medical device regulations or under CE class journey Participates and provide full support in all regulatory audits. Knowledge and experience of CDSCO Should have knowledge of quality control is a plus.

Posted 3 months ago

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