Global Regulatory Affairs Specialist II
3 months ago
Overview
The Regulatory Affairs Specialist II has primary responsibility for provision of 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, 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].
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
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 execute regulatory filings such as 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 Monitor global regulatory intelligence, provide impact evaluation to changing regulations. Performing regulatory impact assessments for engineering changes Review and approve promotional materialsPost Market
Provide regulatory input to support post market surveillance and vigilance activities Support Health Hazard Assessments and Field Actions as needed
Qualifications
Education :
Bachelor’s degree required, preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering. Graduate education is preferable.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 productsSkills:
High fluency 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. Team player demonstrating good organizational and communication skills Self-starting demonstrating initiative
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 more than 60 years. With more than 7,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.
Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We’re the problem solvers and innovators that aren’t afraid to take risks to transform the world of human health and well-being. We’re all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and 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.
-
Global Regulatory Affairs Specialist II
3 months ago
Wexford, Ireland Waters Corporation Full timeResponsibilities 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 execute regulatory filings such as technical files, Canadian submissions, and...
-
Wexford, Ireland Waters Corporation Full timeOverview Key leadership position for Quality, Regulatory and Clinical activities in support of the In Vitro Diagnostic Clinical business. The role will be responsible to work through multiple levels within the organization and external stakeholders to influence and drive Waters Quality, Regulatory & Clinical Affairs strategy to support Waters business...
-
General Adult Psychiatrist
6 months ago
Wexford, Ireland PE Global Locum Express Full timeLocum Express is recruiting for a Locum Consultant in general adult psychiatry based in Co Wexford, Ireland. Job Title: Consultant Psychiatrist – Adults Hours: 39 hours per week with on-call Location: Wexford Mental Health Service Requirements: Valid IMC specialist registration in psychiatry or be eligible for registration. Right to work in Ireland....
-
Principal Design Quality Engineer, Clinical
2 months ago
Wexford, Ireland Waters Corporation Full timeResponsibilities Assume a Subject Matter Expert (SME) role on Product Development process activities and related workflows in relation to regulatory compliance, provide ‘solution-based’ problem resolution Act as Quality specialist in relation to design and development ensuring conformance and up-to-date information on applicable regulatory...
-
Director Clinical Product Solutions
3 weeks ago
Wexford, Ireland Waters Corporation Full timeResponsibilities Acts as a product and business owner for LC-MS/MS solutions specific for clinical diagnostics and therapeutic areas. Be responsible for the VoC and competitive benchmark efforts to identify unmet need and develop value proposition of new product solutions for key therapeutic areas of responsibility. Lead the development of...
-
Director Clinical Product Solutions
3 weeks ago
Wexford, Ireland Waters Corporation Full timeOverview Waters is a leader in life sciences tools, starting with liquid chromatography technologies in the 1960s! Since then, Waters has pioneered analytical techniques across markets including Clinical Diagnostics, Food & Environmental, Pharmaceuticals, and Materials. In Clinical Diagnostics, Waters has leading LC-MS technologies, which are already...
-
Buyer
2 weeks ago
Wexford, Ireland Waters Corporation Full timeOverview We have an exciting opportunity for a Buyer - Global Operations ! You will collaborate with a complementary team who are accountable for both strategic and tactical supply chain activities. This role focuses on supporting management reports & solutions for supply chain operations metrics and business performance. The role also provides...
-
Buyer
1 week ago
Wexford, Ireland Waters Corporation Full timeOverview We have an exciting opportunity for a Buyer - Global Operations ! You will collaborate with a complementary team who are accountable for both strategic and tactical supply chain activities. This role focuses on supporting management reports & solutions for supply chain operations metrics and business performance. The role also provides...
-
Master Data Management Processor
3 days ago
Wexford, Ireland Waters Corporation Full timeOverview The Master Data Management Processor will report to the EMEA Accounts Payable Manager and is responsible for the daily vendor master additions, changes, deletions in accordance with country specific regulatory compliance requirements in the US & EMEA. This role cab be based at either the Wilmslow or Wexford locations, hybrid working. ...
-
Vendor Data Administrator
2 days ago
Wexford, Ireland Waters Corporation Full timeOverview The Master Data Management Processor will report to the EMEA Accounts Payable Manager and is responsible for the daily vendor master additions, changes, deletions in accordance with country specific regulatory compliance requirements in the US & EMEA. This role can be based at either the Wilmslow or Wexford locations, hybrid working. ...
-
Quality & Laboratory Supervisor
3 weeks ago
Wexford Town, Co. Wexford, Ireland Life Science Recruitment Ltd Full timeQuality & Laboratory Supervisor Our client is a world leading supplier of biosecurity & infection control products for the past 50 years. Their dedication to Innovation has been a driving force behind this success. With approx. 1,700 employees across 120 countries, they are committed to driving a significant health impact globally. They are saving lives by...
-
Senior R&D Engineer
3 weeks ago
Wexford Town, Co. Wexford, Ireland BD Medical Full timeJob Description Summary The Senior R & D Engineer works cross-functionally to lead research and development efforts of complex medical devices. The position supports sustaining activities for existing products, focusing on project planning, innovative medical device design, prototype development, testing characterization, analysis and reporting. Job...
