Latest Biochemical Jobs at Waters Corporation | Apply Now for Regulatory Affairs Analyst Role
Are you looking for a rewarding career in regulatory affairs where your expertise can make a global impact? Waters Corporation, a world leader in analytical instruments and scientific technologies, is hiring a Regulatory Affairs Analyst II in Bangalore, India. This role offers an exciting opportunity to support regulatory filings, manage compliance for in vitro diagnostic devices, and contribute to groundbreaking innovations that shape the future of healthcare, food safety, and environmental science.
About Waters Corporation
Waters Corporation (NYSE: WAT) is a global leader in analytical instruments, separations technologies, and software, serving the life, materials, food, and environmental sciences for over 65 years. With over 7,600 employees across more than 100 countries, Waters helps ensure the efficacy of medicines, the safety of food, the purity of water, and the sustainability of products used worldwide.
Job Details
- Job Posting: Regulatory Affairs Analyst II
- Job ID: 23134
- Location: Bangalore, India
- Education: Bachelor’s degree required, preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering. Graduate education is preferable.
- Experience: Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment or equivalent. Knowledge of 21 CFR 820 and ISO 13485 is required.
- Skills: High fluency in English, critical thinking, active listening, technical writing, and able to work effectively in a global function.
Overview
The Regulatory Affairs Specialist II has primary responsibility for the provision of In Vitro Diagnostic regulatory support to prepare, execute, and maintain regulatory filings, including change management, support of post-market requirements, and support of outside vendors, e.g., license holders, in-country representatives.
Responsibilities
Maintaining / Sustaining regulatory filings
- Act as regulatory affairs lead for filing regulatory submissions for existing products in new geographies.
- Develop and maintain regulatory strategies for new and modified products/product families.
New Product Development
- Act as Regulatory Affairs lead for new product development projects.
- Prepare and execute regulatory filings such as technical files and Canadian submissions.
Change Management
- Provide regulatory guidance on changes to existing products.
- Monitor global regulatory intelligence and evaluate the impact of changing regulations.
Post Market
- Provide regulatory input for post-market surveillance and vigilance activities.
- Support Health Hazard Assessments and Field Actions as needed.
Keywords: regulatory affairs analyst, in vitro diagnostic, Latest Biochemical Jobs at Waters, medical device, regulatory filings, global regulations, Job Posting
