Regulatory Affairs Specialist
1 day ago
About 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 Netherlands to further our mission of saving lives and improving patient care. Job Summary: We are seeking a dedicated and knowledgeable Regulatory Specialist to ensure our medical devices meet local and international regulatory standards. The ideal candidate will have extensive knowledge of CDSCO, ISO, FDA, and other regulatory requirements, ensuring the highest standards of safety and efficacy for our products. Key Responsibilities: - Develop regulatory strategies for new/existing products. - Ensure compliance with local/international regulations (CDSCO, ISO, FDA). - Prepare and submit regulatory submissions. - Monitor regulatory developments and adjust strategies. - Liaise with regulatory bodies and internal teams for compliance. - Conduct audits and maintain up-to-date knowledge of regulatory requirements. Required Qualifications: - Bachelor's degree in a scientific discipline. - 5 to 7 years' experience in regulatory affairs within the medical device industry. - In-depth knowledge of CDSCO, ISO, FDA standards. - Experience with regulatory submissions and medical device development. - Excellent communication, organizational, and project management skills. Preferred Qualifications: - Advanced degree (Master's/Ph.D.). - Professional certification in regulatory affairs (RAC).
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Regulatory Affairs Specialist
4 weeks ago
Mumbai, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full timeJob Description Designation : Regulatory Affairs Specialist Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 4 years of experience in regulatory affairs Salary : good hike on current salary Location : Sandhurst Road Mumbai - Head office Essential Duties and Responsibilities: -...
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Regulatory Affairs Operations Specialist
7 days ago
Pune, India Respironics Inc Full timeJob Description Job Title Regulatory Affairs Operations Specialist Job Description Job Responsibilities: - International Registrations - Upload, Verify, and Validate the data with new Regulatory Information to the RIM database - Maintain Registration &Licensing Information - Create Submission Packages for International Registrations - Initiate Renewals with...
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Hyderabad, India Dyaz Innovate Full timeJob Description Company Description Dyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment. Role Description This is a full-time on-site role for a...
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India G&L Scientific Full timeWe are seeking three Global Regulatory Affairs Specialists to provide critical subject matter expertise and backfill internal SMEs during a major regulatory transformation initiative. These roles will ensure continuity of day-to-day regulatory operations - particularly across CMC, labelling, and lifecycle management activities. This opportunity can be...
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Delhi, India Danaher Life Sciences Full timeJob Description - 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 optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that...
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Regulatory Affairs Specialist
3 weeks ago
Goa, India, India UpMan Placements Full timeCore Job Responsibilities:Regulatory Submissions and compliancePrepare 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 FDAPrepare and submit...
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▷ (15h Left) Regulatory Affairs Specialist
4 weeks ago
Hyderabad, India Medtronic Full timeJob Description At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Regulatory Affairs Specialist In this exciting role as a Regulatory Affair...
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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 Specialist
3 weeks ago
Thane, India Cadbury Full timeJob Description Job Description Are You Ready to Make It Happen at Mondelz International Join our Mission to Lead the Future of Snacking. Make It With Pride. You execute the regulatory affairs strategy for your respective category or categories and geographical area using your technical and regulatory knowledge. You ensure our policies, regulatory programs...
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Regulatory Affairs Manager I
1 week ago
Bengaluru, India AstraZeneca Full timeJob Description Job Title: Regulatory Affairs Manager I Global Career Level: D1 Introduction To Role Are you ready to be part of a team that transforms drug development strategies into reality The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and...
