Regulatory Affairs Analyst II

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).

Secondary responsibility would be to provide regulatory support to new product development teams to ensure product requirements / design inputs and design outputs enable identified planned regulatory filings.

The role will work through multiple levels and across functions within the Clinical Business Unit organization to support the growth of the IVD product portfolio.

Responsibilities

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

Change Management

Post Market

Qualifications

Education :

Experience :

Skills :

Company Description

(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.

Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.