Regulatory Affairs Job at Waters Corporation | Biochemistry & Biomedical Candidates, Apply Now
Looking for a strong Regulatory Affairs job in a global science-driven company? Waters Corporation is hiring a Regulatory Affairs Analyst II in Bengaluru, offering an excellent opportunity for candidates skilled in IVD regulations, submissions, change control, and global compliance. This role is ideal for professionals seeking growth in Regulatory Affairs, Biomedical Engineering, and IVD product compliance, along with long-term career pathways at Waters.
- Job Position: Regulatory Affairs Analyst II
- System ID: 23134
- Job Location: Bangalore
About the Company
Waters Corporation (NYSE: WAT) is a world leader in analytical instruments, separation technologies, and scientific software. With over 65 years of innovation and 7,600 employees worldwide, Waters supports laboratories, hospitals, manufacturers, and research centers across 100+ countries. The company plays a key role in ensuring the quality, safety, and sustainability of medicines, food, water, and materials used globally.
Position Overview
The Regulatory Affairs Specialist II is responsible for providing regulatory support for In Vitro Diagnostic (IVD) products, including regulatory filings, change management, post-market support, and working with external regulatory partners such as license holders and in-country representatives. The role also supports new product development teams to ensure regulatory compliance from design inputs to final submissions.
This Regulatory Affairs Job collaborates across multiple levels and global functions within the Clinical Business Unit to support the expansion of Waters’ IVD product portfolio.
Key Responsibilities
Maintaining & Sustaining Regulatory Filings
- Lead regulatory submissions for existing products across global regions.
- Develop and maintain regulatory strategies for new and modified products.
- Conduct international registrations aligned with regulatory strategies.
- Review and approve product labels and global language requirements.
- Support onboarding and management of external vendors such as importers, distributors, and in-country agents.
New Product Development
- Lead Regulatory Affairs activities for new product development projects.
- Provide solution-based regulatory guidance to R&D teams.
- Prepare and execute regulatory filings including technical files, Canadian submissions, and letters to file.
- Conduct international registrations to support new product launches.
- Review and approve labels and global labeling requirements.
- Support external vendor/agent setup for new products.
Change Management
- Provide regulatory assessment for changes made to existing products.
- Monitor global regulatory intelligence and evaluate impacts.
- Perform regulatory impact assessments for engineering changes.
- Review and approve promotional materials.
Post-Market Support
- Provide regulatory input for post-market surveillance activities.
- Support Health Hazard Assessments and Field Actions when required.
Qualifications
Education
- Bachelor’s degree required in Biochemistry or Biomedical Engineering.
Experience
- Experience in Regulatory Affairs within the IVD medical device domain or equivalent.
- Knowledge of 21 CFR 820 and ISO 13485 is essential.
- Strong understanding of India and APAC IVD regulations.
- Hands-on experience preparing regulatory filings such as premarket notifications, license applications, and technical files.
Skills Required
- Excellent English communication skills (written & verbal).
- Strong technical writing, critical thinking, and active listening skills.
- Ability to work collaboratively across global teams and time zones.
- Strong prioritization, organizational, and interpersonal skills.
- High work ethic, initiative, and team-oriented approach.
This Regulatory Affairs job at Waters offers an excellent platform for professionals in biomedical engineering, IVD compliance, and regulatory strategy. With opportunities to work on global submissions, new product development, and complex regulatory challenges, this role provides strong career growth within the renowned Waters Corporation.
