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
1 day ago
bangalore, 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
2 weeks ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or InjectablesLevel - Deputy Manager/ Associate ManagerRequired Education/Exp:Experience Req.: 8 - 12 yrs.Qualification: - M. Pharma / M.Sc.Key Role- Formulation Regulatory Affairs for Peptide products or InjectablesResponsibilities:Drafting controlled correspondences, pre-development meetings and...
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Regulatory Affairs Specialist
2 weeks ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or Injectables Level - Deputy Manager/ Associate Manager Required Education/Ex p: Experience Req.: 8 - 12 yrs. Qualification: - M. Pharma / M.Sc. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Responsibiliti es: Drafting controlled correspondences, pre-development...
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Regulatory Affairs Specialist
2 weeks ago
Bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or Injectables Level - Deputy Manager/ Associate Manager Required Education/Ex p: Experience Req.: 8 - 12 yrs. Qualification: - M. Pharma / M.Sc. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Responsibiliti es: Drafting controlled correspondences, pre-development...
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Regulatory Affairs Manager I
2 weeks ago
Bangalore, Karnataka, India AstraZeneca Full timeJob 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 execution of assigned...
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Regulatory Affairs Executive
2 weeks ago
bangalore, India Halma plc Full timeAbout Halma:Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
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Scientific and Regulatory Affairs Consultant
2 weeks ago
Bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or Injectables Required Education/Ex p: Experience Req.: 8 - 12 yrs. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Drafting controlled correspondences, pre-development meetings and scientific advices for seeking regulatory feedback on various topics from different...
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Regulatory Affairs Executive
2 weeks ago
bangalore, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
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Regulatory Affairs Executive
2 weeks ago
Bangalore, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
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Regulatory Affairs Executive
1 week ago
Bangalore, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
