Regulatory Affairs Specialist
4 weeks ago
Job Title: Regulatory Affairs Junior ManagerLocation:At Ahmedabad Office , Near Thaltej Crossroads Department:RA Reports To:RA Head and Regulatory Department at HO /Director Employment Type:Full Time Office hours : 9,30 AM to 6 PM Week of: Sunday andSaturday Half Day Preferred Gender: M/F Experience : Minimum 2 yearsJob Summary: We are seeking a proactive and detail-orientedRegulatory Affairs Executiveto support the regulatory compliance activities forClass III medical devices . The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management.Key Responsibilities: Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.g., US FDA, EU MDR, India CDSCO, etc.). Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments. Support product development teams with regulatory input during the design and development phases. Conduct regulatory impact assessments for design or process changes. Monitor and interpret evolving global regulations and standards applicable to Class III medical devices. Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits. Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations. Assist in internal audits and inspections, including document preparation and response coordination. Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements. Participate in risk management, clinical evaluation, and post-market surveillance activities.Qualifications: Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field. Minimum2 years of hands-on experiencein regulatory affairs, specifically withClass III medical devices . Knowledge of medical device regulations such asEU MDR ,US FDA 21 CFR Part 820 ,ISO 13485 , andCDSCOrequirements. Experience in dossier preparation (e.g., 510(k), PMA, CE technical files). Strong analytical, organizational, and communication skills. Attention to detail and ability to work independently as well as in a team environment.Preferred Qualifications: Certification in Regulatory Affairs (e.g., RAC) is a plus. Experience interacting with regulatory bodies or notified bodies. Familiarity with eCTD or electronic submission platforms.
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Regulatory Affairs Specialist
3 days ago
Delhi, India Concept Medical Full timeAbout Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in...
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Regulatory Affairs Specialist
3 days ago
Delhi, India Concept Medical Full timeAbout Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...
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Regulatory Affairs Specialist Oligonucleotides
21 hours ago
New Delhi, India Dr. Reddy's Laboratories Full timeJob SummaryWe are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
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Regulatory Affairs Specialist
3 days ago
Delhi, India Dr. Reddy's Laboratories Full timeJob Summary We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
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Regulatory Affairs Specialist
3 weeks ago
New Delhi, India UpMan Placements Full timeCore Job Responsibilities: Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA Prepare and submit...
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New Delhi, India Danaher Full timeThis job is with Danaher, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Wondering what’s within Beckman Coulter Diagnostics? Take a closer look. At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and...
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Regulatory Affairs Specialist
2 weeks ago
New Delhi, India Shiv Nadar School Full timeJob Title:Senior Manager –Regulatory Affairs & Legal Compliances Location:Core Office, Noida Employment Type:Full-timeJob Summary: We are seeking a detail-oriented and proactive professional to oversee the organization’s legal, regulatory, and compliance functions. The incumbent will be responsible for ensuring adherence to statutory requirements,...
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Regulatory Affairs Specialist
1 week ago
New Delhi, India Shiv Nadar School Full timeJob Title: Senior Manager – Regulatory Affairs & Legal CompliancesLocation: Core Office, NoidaEmployment Type: Full-timeJob Summary:We are seeking a detail-oriented and proactive professional to oversee the organization’s legal, regulatory, and compliance functions. The incumbent will be responsible for ensuring adherence to statutory requirements,...
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Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Delhi, NCR, Vellore, India Airvin Skills Full time ₹ 2,00,000 - ₹ 8,00,000 per yearEWe are looking for a passionate and detail-oriented Regulatory Affairs Specialist (Fresher) to join our life sciences and healthcare compliance team. The ideal candidate will be responsible for assisting in the preparation, review, and submission of regulatory documents and ensuring adherence to national and international standards for product approval and...
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Regulatory Affairs Specialist
6 days ago
Delhi, Delhi, India DSS Imagetech Pvt Ltd Full time ₹ 15,00,000 - ₹ 25,00,000 per yearThis is a full-time, on-site position based in New Delhi for a Regulatory Affairs Specialist. The role involves effective communication and coordination withboth internal teams and external stakeholders to ensure regulatory compliance and smooth operational workflows.Key Responsibilities:Develop and implement procedures to ensure regulatory compliance across...
