Regulatory Affairs Analyst Job at Waters Corporation, Apply Now!
Are you experienced in regulatory affairs for In Vitro Diagnostic (IVD) medical devices? Join Waters Corporation as a Regulatory Affairs Analyst II at our Bangalore office, where you will contribute to regulatory strategy, global submissions, change management, and compliance activities. This is a high-impact role supporting our expanding IVD product portfolio across multiple markets.
Job Title: Regulatory Affairs Analyst II
Location: Bangalore, Karnataka, India
Company: Waters Corporation
Department: Legal (Regulatory Affairs)
Job System ID: 23134
Company Overview: 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. Our Company helps ensure the efficacy of medicines, the safety of food and the purity of water, and the quality and sustainability of products used every day. In over 100 countries, our 7,600+ passionate employees collaborate with customers in laboratories, manufacturing sites, and hospitals to accelerate the benefits of pioneering science.
Overview:
The Regulatory Affairs Specialist II has primary responsibility for 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 for new geographies.
- Develop and maintain regulatory strategies for new and modified product / product families.
- 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 set up 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, provide “solution-based” advice to development teams.
- Develop and maintain regulatory strategies for new and modified product / product families.
- Prepare and execute regulatory filings such as technical files, Canadian submissions, and letters to file as Regulatory Affairs.
- 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 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 as Regulatory Affairs.
- 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
Education:
Bachelor’s degree required, preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering. Graduate education is preferable for Regulatory Affairs.
Experience:
- Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment, or equivalent for Regulatory Affairs.
- Knowledge and application of 21 CFR 820 and ISO 13485 is required.
- Knowledge and application of the India and APAC specific IVD regulations is 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 as Regulatory Affairs.
- Strong ability to work with individuals/teams dispersed across many different locations, timezones 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.
Keywords: Regulatory Affairs Analyst, Waters Corporation, Job Posting, In Vitro Diagnostic, Regulatory Support, Regulatory Filings, Product Development, Regulatory Strategies, Post Market, Qualifications, Skills
