Regulatory Affairs Specialist II

Overview

Waters is looking for a Regulatory Affairs professional to work through multiple levels and across functions within the Clinical Business Unit organization to support the growth of the IVD product portfolio.

Provide In Vitro Diagnostic regulatory support to new product development teams to ensure product requirements/design inputs and design outputs enable identified planned regulatory filings.

Prepare, implement, and maintain regulatory filings, including change management, supporting post-market requirements and supporting outside vendors [e.g. license holders, in-country representatives].

Responsibilities

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 implement regulatory filings, including 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 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
- Supervise global regulatory intelligence and provide impact evaluation of 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

Leadership

- Support generating a strong Quality culture within the Clinical Business Unit through effective collaboration with peers.
- Act as Subject Matter Expert within 3rd party and internal audits
- Manage and maintain Regulatory Affairs internal policies and procedures
- Provide guidance to regulatory specialists as needed to support regulatory and/or clinical strategy requirements.

Qualifications

Education:

A bachelor's degree or equivalent experience is required, preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering. Graduate education or equivalent experience is preferred.

Experience:

- Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment, or equivalent
- Knowledge and application of 21 CFR 820 and ISO 13485 is required
- Knowledge and application of the European IVD regulations is required, IVDR preferred
- First-hand experience with preparation and execution of regulatory filings such as pre-Submissions, premarket notifications, & technical files for US & EU regulatory approval, preferably for clinical IVD products
- Desirable – experience of regulatory filings in China, Australia, Canada and APAC

Proficiencies:

- High proficiency 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 and cultures
- Strong organization/prioritization skills
- Outstanding Work Ethic.
- Effective communication and influencing skills.
- Supportive team member exhibiting excellent organizational and communication competencies
- Self-starting, demonstrating initiative

Travel (If Applicable):

Dedication to a minimum of 60% in-person/office, including an average of 2 travel trips annually

Company Description

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.

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.

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