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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