Regulatory Affairs Specialist for Dossier Preparation

Job SummaryWelcome to Dozee, a pioneering healthcare company seeking a seasoned Regulatory Affairs Specialist to spearhead our medical device compliance efforts. This is an exceptional opportunity for a highly motivated individual with expertise in navigating the complex landscape of medical device regulations.About the RoleWe are looking for a seasoned...

**Job Summary:**We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Dozee. This role will be responsible for ensuring compliance with local and international regulations, including US FDA, EU MDR, and ISO 13485.The ideal candidate will have a strong understanding of medical device regulations, experience with international...

Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Dozee. As a key member of our Quality Assurance department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.About the RoleThis is a fantastic opportunity for an experienced professional to leverage...

Company OverviewLifelancer is a leading talent-hiring platform in the Life Sciences, Pharma, and IT sectors. Our mission is to connect top talent with opportunities in these fields. Job Title: Regulatory Affairs ManagerSalary: $120,000 - $180,000 per yearLocation: Remote or On-Site (Flexible)Job Description:We are seeking an experienced Regulatory Affairs...

OverviewSurgeWay Biosciences is a fast-growing organization committed to providing opportunities for growth and development. We are seeking a highly skilled Regulatory Affairs Executive to join our team.Estimated Salary: $60,000 - $80,000 per yearJob Description:The successful candidate will be responsible for preparing and compiling registration dossiers as...

Job Title: Regulatory Affairs SpecialistIn this role at Biocon, you will be responsible for handling regulatory affairs for pharmaceutical products in the US market. Your primary focus will be on preparing and submitting ANDA/ANDS applications to the FDA.Key Responsibilities:Hands-on experience in preparing, reviewing, and submitting ANDA/ANDS applications...

Job SummaryWe are seeking a seasoned Regulatory Affairs Specialist to join our team at Biocon. As a key member of our formulation and submissions team, you will be responsible for preparing, reviewing, and submitting ANDA/ANDS in the US market, ensuring compliance with regulatory guidelines.The ideal candidate will have hands-on experience with life cycle...

Job Description:As a Medical Device Regulatory Affairs Specialist at Dozee, you will play a pivotal role in ensuring the company's products meet regulatory requirements. Your primary responsibility will be to plan, establish, and maintain a Quality Management System (QMS) in accordance with EN ISO 13485. This involves implementing regulatory strategies for...

Job Description Overview:ScaleneWorks seeks a skilled Regulatory Affairs Specialist to lead our regulatory efforts. As a key member of the team, you will be responsible for ensuring the compliance of our products with relevant regulations.About the Role:This is an exciting opportunity to join ScaleneWorks as a Regulatory Affairs Specialist. You will be...

**Job Title:** Regulatory Affairs ProfessionalAbout the Role:We are seeking an experienced Regulatory Affairs Professional to join our team at Apotex. As a key member of our Regulatory Affairs department, you will be responsible for preparing and submitting regulatory documents, including drug master files, amendments, and annual reports.Key...

Baxter is a leading global innovator of medical products, with a legacy spanning nearly 70 years. Our journey towards separating the $5B Kidney Care segment into a standalone company has brought about an exciting opportunity to revolutionize kidney care and other vital organ support.As a Regulatory Affairs Specialist for Kidney Care Product Development, you...

Job Title: Regulatory Affairs SpecialistLocation: Bengaluru, Karnataka, IndiaContract Type: Full-timeSeniority Level: Mid-Senior levelAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer. In this role, you will be responsible for ensuring compliance with various food regulations and laws in...

Job Title: Regulatory Affairs Specialist for Medical DevicesLocation: Bengaluru, Karnataka, IndiaContract Type: Full-timeSeniority Level: Mid-Senior levelLifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We connect talented professionals with opportunities in pharma, biotech, health sciences, healthtech and IT domains.Estimated Salary:...

Vantive: Revolutionizing Kidney CareBaxter is transforming its Kidney Care segment into a standalone company, Vantive. This new entity will leverage Baxter's legacy in acute therapies and home and in-center dialysis to deliver best-in-class care to patients worldwide.As a Regulatory Affairs Specialist at Vantive, you will be part of a community driven to...

About the OpportunityGainwell Technologies is a leading technology company that values innovation and excellence. We are seeking a Regulatory Affairs Specialist to join our team and play a critical role in ensuring compliance with regulatory requirements.Key ResponsibilitiesDevelop and update compliance policies and procedures.Disseminate regulations to...

**About Lifelancer**Lifelancer is a global talent-hiring platform that connects professionals with opportunities in the life sciences, pharma, and IT industries. Our goal is to help individuals advance their careers while promoting equal opportunities for people with disabilities. **Company Overview**Lilly is a global healthcare leader headquartered in...

Vantive: Revolutionizing Kidney Care Baxter is a leading healthcare company on a mission to separate our ~$5B Kidney Care segment into a standalone company, Vantive. With nearly 70 years of experience in acute therapies and home and in-center dialysis, we aim to provide best-in-class care to those we serve. The role of Regulatory Affairs Specialist Lead is...

About ElancoAt Elanco, we're a global leader in animal health. Our mission is to advance the health of animals, people, and the planet.Job SummaryWe're seeking a Regulatory Affairs Specialist to work with our cross-functional teams to develop regulatory strategies, oversee submission preparation, and meet reporting requirements for new animal drugs with...

Job SummaryWe are seeking a seasoned Senior Regulatory Affairs Specialist to join our dynamic team at AliveCor. As a key member of the regulatory team, you will play a crucial role in overseeing medical device development and market introduction worldwide.Your primary responsibility will be to manage product submissions, perform regulatory pre- and...

Job Overview: We are seeking an experienced Compliance Officer to join our team at Avenue Code. The ideal candidate will have a strong background in compliance, risk management, and regulatory affairs. This is a full-time position with a competitive salary of $120,000 per year.