Regulatory Affairs Specialist
13 hours 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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Executive Regulatory Affairs
3 days ago
Surat, India Trident Lifeline Pvt. Ltd. Full time**Job Description & Responsibilities.** - Ensure that a company's products comply with the regulations of the regions where they want to distribute them. - Keep up to date with national and international legislation, guidelines, and customer practices - Collect, collate, and evaluate scientific data from a range of sources Develop and write clear arguments...
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Regulatory Specialist and Senior Specialist
12 hours ago
Surat, India Concept Medical Full timeConcept 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
23 hours ago
Surat, Gujarat, India SALVAVIDAS PHARMACEUTICAL Full time**Roles & Responsibility**: - Prepare, compile, and submit regulatory documents to health authorities (e.g., FDA, EMA, MOH) for product approvals, renewals, and variations. - Ensure all submissions are accurate, complete, and submitted in a timely manner. - Ensure compliance with all local, national, and international regulations and standards for...
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Regulatory Affairs Manager
2 days ago
Surat, India Seven Consultancy Full timeJOB DETAILS Studying scientific and legal documentsGathering, evaluating, organising, managing and collating information in a variety of formats Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA) Maintaining familiarity with company product ranges Planning, undertaking and overseeing product trials and...
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Regulatory Affairs Executive
1 week ago
Surat, Gujarat, India Trident Lifeline Full time ₹ 5,00,000 - ₹ 15,00,000 per yearONLY EXPERIENCE CANDIDATE CAN APPLYJob description: -We are looking for a Regulatory Affairs Executive with strong knowledge of pharmaceutical products. The candidatemust have experience in domestic regulatory compliance (FSSAI/CDSCO) and export documentation, specifically forLATAM & ROW. Responsibilities include dossier preparation, label review, and...
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Regulatory Affairs Officer
3 days ago
Surat, India Royal Services Full timeWe have urgent opening for our client: - Location: - Surat ( Sachin GIDC ) Plant: - Pharmaceutical (Formulation Plant ) Qualification: - B.pharm/M.pharm Experience: - 6 month -7 year in RA ( Regulatory Affairs ) Post: - RA Officer Job Time: - 8 hour shift Salary: - Negotiable Facility: - No Job Type: - Permanent Job No.of vacancy: - 01...
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Regulatory Affairs Executive
1 week ago
Surat, Gujarat, India Discrete Circuits Pvt. Ltd Full time ₹ 4,00,000 - ₹ 12,00,000 per yearAbout the Company Embarking on the frontier of technological progress, Discrete Circuits Pvt. Ltd. takes pride in its commitment to pioneering innovation and delivering state-of-the-art solutions that dynamically cater to our customers' evolving needs. Our journey unfolds through a comprehensive process, beginning with extensive research, leading to...
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Regulatory Affairs Executive
2 weeks ago
Slabatpura, Surat, Gujarat, India Trident Lifeline Pvt. Ltd. Full time**Job Summary**: The Regulatory Affairs Executive will be responsible for ensuring that the company’s products comply with all regulations and guidelines of relevant regulatory authorities. The role involves preparing, compiling, and submitting regulatory documents, liaising with authorities, and maintaining regulatory compliance across domestic and...
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Regulatory Affairs Executive
23 hours ago
Sachin, Surat, Gujarat, India HARE MURARI PLACEMENT SERVICE Full timeUrgent Requirement Regulatory AFFAIRS -EPC LOCATION SURAT SACHIN SALARY AS PER INTERVIEW EXPERIENCE 5 TO 10 YEARS **Job Types**: Full-time, Permanent **Salary**: ₹50,000.00 - ₹75,000.00 per month **Benefits**: - Provident Fund Schedule: - Day shift - Morning shift Supplemental pay types: - Yearly bonus Ability to commute/relocate: - Sachin...
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Regulatory Affairs Executive
1 week ago
Surat, India Invent Bio-med Private Limited Full time1. Company's products comply with the regulations of the regions where they want to distribute them (as per MDR-2017, EUMDR 2017 etc..) 2. Keep up to date with national and international legislation, guidelines and customer practices / requirements 3. Collect, collate and evaluate scientific data from a range of sources 4. Prepare and submissions of...