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Senior Clinical Evaluation & Regulatory Affairs Specialist

Company: Waters Corporation
Location: Milford
Posted on: September 12, 2020

Job Description:

Senior Clinical Evaluation & Regulatory Affairs Specialist Req. # 12076

Company Name Waters Division

Category Legal

Location US-MA-Milford

Type Regular Full-Time

Overview The Clinical Evaluation & Regulatory Affairs Specialist is responsible for the long-term strategy for developing and maintaining sufficient clinical evidence to support the clinical evaluation over the life-cycle of the Waters in vitro diagnostic medical devices.

This role  has primary responisibility for providing guidance to new product development teams and post market vigilance teams for mature products to identify and assess clinical evidence required to support Waters in vitro diganostic medical devices. The Clinical Evaluation & Regulatory Affairs Specialist will develop and facilitate clinical performance evaluation plans, conduct post market clinical literature reviews, and draft performance evaluation reports in support of 2017/746 Annex XIII technical documentation requirments. This role is also reponsible to select and manage external clinical research organizations to ensure performance evaluations are conducted according to plan, and is also responsible to liason with Waters’ external medical advisor in support of health hazard assessments. The Clinical Evaluation & Regulatory Affairs Specialist is also responsible for interactions with FDA regarding all clinical studies and activities pretinent to significant risk determination, Pre-IDE, and IDE submissions.

Secondary resonsibilities include drafting and updating regulatory strategies to support new product development team, sustaining engineering projects as well as promotional material review and approval.

The Clinical Evaluation & Regulatory Affairs Specialist requires a strong candidate with experience in medical writing of clinical regulatory documents and works independently with a high degree of critical analysis.

Responsibilities Participate as a core team member on new product development teams to support risk analysis through post market clinical literature reviews and to provide guidance

on clinical performance study design and regulatory planning.

Liaison with bio-statistician and external CRO to ensure adequate study design

Provide input to the clinical requirements section of regulatory strategies for new and modified products

Support regulatory affairs for pre-IDE submissions as assigned

Prepare Clinical Performance Evaluation Reports per 2017/746

Prepare clinical performance sections for international regulatory submissions as assigned

Conduct comprehensive post market clinical literature reviews per MEDDEV 2.7.1

Manage clinical performance studies or external CRO lead studies in accordance with ISO 20916

Support Health Hazard Assessments as needed

Cooperate with Medical Advisor on Health Hazard Assessments, Risk Analysis and Clinical Literature Reviews

Provide guidance to regulatory specialists as needed to support clinical strategy requirements

Mentor Regulatory Specialists on Clinical Evidence

Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)

Qualifications Bachelor’s degree required preferably in science or engineering.

Advanced degree and/or RAC certification is an advantage

Must have a minimum of 4 years of medical writing experience

Minimum of 2-4 years of experience in clinical evaluation report writing in a medical device industry is preferred.

Previous clinical evidence and regulatory affairs experience in the application of therapeutic and In Vitro Diagnostic medical device knowledge to development of clinical evaluation strategy, systematic literature reviews, preparation of clinical evaluation reports and regulatory strategies in a Medical Device environment

Experience in conducting literature searches, reviews and appraisal of the scientific data.

Demonstrated effective scientific writing skills

Excellent critical and analytical thinking skills.

Must have high level of attention to detail, accuracy and organization.

Must be able to work effectively on cross-functional teams to manage multiple projects across disciplines and ensure adherence to timelines

Strong communication, presentation and interpersonal skills

Working knowledge of statistics to apply and understand appropriate study design and systematic literature review is an advantage

In-depth knowledge of In Vitro Diagnostic regulatory process (CE Marking, IDE, 510(k), post-market/post approval), GCP procedures, and legal compliance for medical device industry

Knowledge of LC/MS/MS and Software regulations is a plus

Travel:

Ability to travel 5-15% (once travel restrictions ease/safe to do so)

Company Description Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials and food sciences for 60 years. With approximately 7,000 employees worldwide, Waters operates directly in 31 countries, including 15 manufacturing facilities, and with products available in more than 100 countries.

Waters Corporation's businesses include Waters, TA Instruments, VICAM, ERA, and Nonlinear Dynamics.

Waters creates business advantages for laboratory-dependent organizations by delivering ultra performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), chromatography columns and chemistry products, mass spectrometry systems, laboratory informatics solutions, and comprehensive service programs to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.

Diversity and inclusion are fundamental to our core values at Waters Corporation. Celebrating diversity is important to us. We thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.

Key Words regulatory affairs, clinical, ivdr, 510(k), IDE, CE marking, Clinical Performance Evaluation Reports, 2017/746

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Keywords: Waters Corporation, Milford , Senior Clinical Evaluation & Regulatory Affairs Specialist, Other , Milford, Connecticut

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