MilfordRecruiter Since 2001
the smart solution for Milford jobs

Senior Clinical Evaluation & Regulatory Affairs Specialist

Company: Waters Corporation
Location: Milford
Posted on: September 16, 2020

Job 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. 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

* Self-starting demonstrating initiative

* 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 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., * 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 * Self-starting demonstrating initiative * 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)

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Amazon Package Sorter - Immediate Openings!
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: North Haven, CT Job opportunities vary by location. We update postings daily with open positions. Hourly pay rate: (more...)
Company: Amazon
Location: Westport
Posted on: 09/23/2020

Amazon Shopper
Description: Shifts: Overnight, Early Morning, Day, Evening, WeekendLocation:Trumbull, CTStratford, CTFairfield, CTMilford, CTJob opportunities vary by location. We update postings daily with open positions.Hourly (more...)
Company: Amazon Workforce Staffing
Location: Westport
Posted on: 09/23/2020

Whole Foods Shopper - Fairfield
Description: Shifts: br Overnight, Early Morning, Day, Evening, Weekend br br Location: br Trumbull, CT br Stratford, CT br Fairfield, CT br Milford, CT br br Job opportunities vary by location. (more...)
Company: Amazon Workforce Staffing
Location: Westport
Posted on: 09/23/2020


Amazon Workforce Staffing: Warehouse Team Member
Description: Warehouse
Company: Amazon Workforce Staffing
Location: Westport
Posted on: 09/23/2020

Amazon Workforce Staffing: Amazon Warehouse Handler - Benefits Day One
Description: Warehouse
Company: Amazon Workforce Staffing
Location: Westport
Posted on: 09/23/2020

Amazon Warehouse $15.75 - $18.15 hr (North Haven)
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: North Haven, CT Job opportunities vary by location. We update postings daily with open positions. Hourly pay rate: Earn 15.25- 19.25 (more...)
Company: Amazon Workforce Staffing
Location: Westport
Posted on: 09/23/2020

Amazon Order Picker/Packer
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: North Haven, CT Job opportunities vary by location. We update postings daily with open positions. Hourly pay rate: Earn 15.25- 19.25 (more...)
Company: Amazon Workforce Staffing
Location: Westport
Posted on: 09/23/2020

Insurance Representative - Fairfield, CT
Description: Quick Facts: ul li Insurance Sales New and Existing Clients li Leadership Positions Available - Licensed Agents Fast-Tracked li Career Changers welcome - Experience not necessary - Training (more...)
Company: Colonial Life
Location: Westport
Posted on: 09/23/2020

Amazon Order Filler - Immediate Hire (North Haven)
Description: Shifts: Overnight, Early Morning, Day, Evening, WeekendLocation:North Haven, CTStratford, CTFairfield, CTMilford, CTTrumbull, CTJob opportunities vary by location. We update postings daily with open positions.Hourly (more...)
Company: Amazon Workforce Staffing
Location: Westport
Posted on: 09/23/2020

Amazon Order Picker/Packer
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: North Haven, CT Job opportunities vary by location. We update postings daily with open positions. Hourly pay rate: (more...)
Company: Amazon
Location: Westport
Posted on: 09/23/2020

Log In or Create An Account

Get the latest Connecticut jobs by following @recnetCT on Twitter!

Milford RSS job feeds