Waters Corporation Careers: Regulatory Affairs Job | Analytical Chemistry Job
Are you looking for an exciting regulatory affairs job in the In Vitro Diagnostic (IVD) industry? Join Waters Corporation careers in Bangalore, India, as a Regulatory Affairs Analyst II. This opportunity is perfect for professionals with a Chemistry job background, offering the chance to lead regulatory filings, support new product development, and collaborate with global teams to drive innovation in clinical diagnostics.
About Waters Corporation
Waters Corporation is a global leader in analytical instruments, laboratory technologies, and clinical diagnostic solutions. With a strong commitment to innovation, the company supports scientific advancements across pharmaceuticals, life sciences, food safety, and environmental testing. Waters is known for its high-quality systems, regulatory excellence, and customer-focused approach. Through its global network, the company empowers scientists and healthcare professionals to deliver accurate, reliable results. As part of Waters Corporation careers, employees join a collaborative culture that values integrity, innovation, and continuous learning, offering meaningful opportunities for professionals in regulatory affairs, chemistry, and related scientific fields.
Job Details
- Job Title: Regulatory Affairs Analyst II
- Job ID: 23134
- Location: IN-KA-Bangalore, India
Overview
The Regulatory Affairs Analyst II role at Waters Corporation provides key support for In Vitro Diagnostic
(IVD) regulatory activities. Responsibilities include preparing, executing, and maintaining regulatory filings, change management, post-market support, and collaboration with external vendors such as license holders and in-country representatives.This regulatory affairs job also supports new product development teams to ensure product design and development align with planned regulatory filings. The position involves working across multiple levels and functions within the Clinical Business Unit to support the growth of the IVD product portfolio.
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.
- Conduct international registrations in accordance with and in support of the regulatory strategy.
- Provide input on and approve product labels and labelling, including language requirements worldwi.de
- Support the setup and management of outside vendors such as License holders and In Country agents [including importers, distributors], as needed.
New Product Development
- Act as Regulatory Affairs lead for the new product development projects, and provide “solution-based” advice to development teams
- Develop and maintain regulatory strategies for new and modified products/product families
- Prepare and execute regulatory filings such as technical files, Canadian submissions, and letters to file.
- Conduct international registrations in accordance with and in support of regulatory strategies
- Provide input on and approve product labels and labelling including language requirements worldwide
- Support the set up and management of outside vendors such as License holders and In Country agents [including importers, distributors], as needed.
Change Management
- Provide regulatory guidance on changes to existing products
- Monitor global regulatory intelligence, provide impact evaluation to changing regulations.
- Performing regulatory impact assessments for engineering changes
- Review and approve promotional materials
Post Market
- Provide regulatory input to support post-market surveillance and vigilance activities
- Support Health Hazard Assessments and Field Actions as needed
Qualifications: 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 and application of 21 CFR 820 and ISO 13485 are required
- Knowledge and application of the India and APAC-specific IVD regulations are required
- First-hand experience with preparation and execution of regulatory filings such as premarket notifications, licence applications & technical files, preferably for clinical IVD products
Skills:
- High fluency in English, verbal and written
- Critical Thinking, Active Listening, and Technical Writing Skills
- Able to work effectively in a global function
- Strong ability to work with individuals/teams dispersed across many different locations, time zones, and cultures (US, EU, China, India, Australasia)
- Strong organization/prioritization skills
- Outstanding Work Ethic.
- Effective communication and influencing skills.
- Team player demonstrating good organizational and communication skills
- Self-starting, demonstrating initiative.
