Global Regulatory Affairs Specialist II
2 weeks ago
The Regulatory Affairs Specialist II will play a key role in ensuring the company's In Vitro Diagnostic products meet regulatory requirements. This includes providing regulatory support to new product development teams, preparing and executing regulatory filings, and maintaining regulatory intelligence.
Key Responsibilities
New Product Development
• Act as the primary regulatory contact for new product development projects, providing expert advice to development teams.
• Develop and maintain regulatory strategies for new and modified products, ensuring compliance with global regulations.
• Prepare and execute 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 labeling, ensuring language requirements are met worldwide.
Change Management
• Provide regulatory guidance on changes to existing products, ensuring compliance with global regulations.
• Monitor global regulatory intelligence, providing impact evaluations on changing regulations.
• Perform regulatory impact assessments for engineering changes, ensuring compliance with global regulations.
• Review and approve promotional materials, ensuring compliance with global regulations.
Post Market
• Provide regulatory input to support post-market surveillance and vigilance activities, ensuring compliance with global regulations.
• Support Health Hazard Assessments and Field Actions as needed, ensuring compliance with global regulations.
Qualifications
• Bachelor's degree in Analytical Chemistry, Biochemistry, or Biomedical Engineering, or equivalent experience.
• Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment, or equivalent experience.
• Knowledge and application of 21 CFR 820 and ISO 13485, as well as European IVD regulations, are required.
• First-hand experience with preparation and execution of regulatory filings, such as pre-Submissions, premarket notifications, and technical files, for US and EU regulatory approval, preferably for clinical IVD products.
Company Description
Waters Corporation is a leading specialty measurement company, pioneering innovations in chromatography, mass spectrometry, and thermal analysis. With a global presence and a commitment to diversity and inclusion, Waters Corporation is a great place to grow your career and make a difference in the world of human health and well-being.
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Global Regulatory Affairs Specialist II
4 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob Title: Global Regulatory Affairs Specialist IIWaters Corporation is seeking a highly skilled Global Regulatory Affairs Specialist II to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory guidance and support for new product development, change management, and post-market...
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Global Regulatory Affairs Specialist II
4 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob Title: Global Regulatory Affairs Specialist IIWaters Corporation is seeking a highly skilled Global Regulatory Affairs Specialist II to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory guidance and support for new product development, change management, and post-market...
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Global Regulatory Affairs Specialist II
4 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob Title: Global Regulatory Affairs Specialist IIWaters Corporation is seeking a highly skilled Global Regulatory Affairs Specialist II to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory support to new product development teams to ensure compliance with global...
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Global Regulatory Affairs Specialist II
4 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob Title: Global Regulatory Affairs Specialist IIWaters Corporation is seeking a highly skilled Global Regulatory Affairs Specialist II to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory support to new product development teams to ensure compliance with global...
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Regulatory Affairs Specialist II
4 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob Title: Global Regulatory Affairs Specialist IIWaters Corporation is seeking a highly skilled Global Regulatory Affairs Specialist II to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory guidance and support to our development teams, ensuring compliance with global regulatory...
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Regulatory Affairs Specialist II
4 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob Title: Global Regulatory Affairs Specialist IIWaters Corporation is seeking a highly skilled Global Regulatory Affairs Specialist II to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory guidance and support to our development teams, ensuring compliance with global regulatory...
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Global Regulatory Affairs Specialist II
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Wilmslow, Cheshire East, United Kingdom Waters Full timeRegulatory Affairs Specialist IIKey ResponsibilitiesProvide regulatory guidance and support to new product development teams to ensure compliance with regulatory requirementsDevelop and maintain regulatory strategies for new and modified productsPrepare and execute regulatory filings, including technical files and Canadian submissionsConduct international...
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Global Regulatory Affairs Specialist II
3 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeRegulatory Affairs Specialist IIKey ResponsibilitiesProvide regulatory guidance and support to new product development teams to ensure compliance with regulatory requirementsDevelop and maintain regulatory strategies for new and modified productsPrepare and execute regulatory filings, including technical files and Canadian submissionsConduct international...
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2 months ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Waters Corporation. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory support to new product development teams to ensure compliance with regulatory requirements.Key ResponsibilitiesRegulatory SupportAct as...
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Global Regulatory Affairs Specialist II
2 months ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Waters Corporation. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory support to new product development teams to ensure compliance with regulatory requirements.Key ResponsibilitiesRegulatory SupportAct as...
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Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryThe Regulatory Affairs Specialist II will provide regulatory support to new product development teams to ensure product requirements/design inputs and design outputs enable identified planned regulatory filings. This role will work through multiple levels and across functions within the Clinical Business Unit organization to support the growth of...
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Global Regulatory Affairs Specialist II
3 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryThe Regulatory Affairs Specialist II will provide regulatory support to new product development teams to ensure product requirements/design inputs and design outputs enable identified planned regulatory filings. This role will work through multiple levels and across functions within the Clinical Business Unit organization to support the growth of...
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Regulatory Affairs Specialist II
2 months ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Waters Corporation. As a key member of our Clinical Business Unit, you will be responsible for providing regulatory support to new product development teams, ensuring compliance with global regulations and standards.Key ResponsibilitiesDevelop and maintain...
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Regulatory Affairs Specialist II
2 months ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Waters Corporation. As a key member of our Clinical Business Unit, you will be responsible for providing regulatory support to new product development teams, ensuring compliance with global regulations and standards.Key ResponsibilitiesDevelop and maintain...
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Regulatory Affairs Specialist II
2 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob SummaryThe Regulatory Affairs Specialist II will provide regulatory support to new product development teams, ensuring compliance with regulatory requirements and facilitating successful product launches. This role will work closely with cross-functional teams to develop and maintain regulatory strategies, prepare and execute regulatory filings, and...
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Global Regulatory Affairs Specialist II
1 month ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Waters Corporation. As a key member of our Clinical Business Unit, you will be responsible for providing regulatory support to new product development teams, ensuring compliance with global regulations and standards.Key ResponsibilitiesDevelop and maintain regulatory...
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Global Regulatory Affairs Specialist II
1 month ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Waters Corporation. As a key member of our Clinical Business Unit, you will be responsible for providing regulatory support to new product development teams, ensuring compliance with global regulations and standards.Key ResponsibilitiesDevelop and maintain regulatory...
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Global Regulatory Affairs Specialist II
1 month ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Waters Corporation. As a key member of our Clinical Business Unit, you will be responsible for providing regulatory support to new product development teams, ensuring compliance with global regulations and standards.Key ResponsibilitiesDevelop and maintain regulatory...
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Global Regulatory Affairs Specialist II
1 month ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Waters Corporation. As a key member of our Clinical Business Unit, you will be responsible for providing regulatory support to new product development teams, ensuring compliance with global regulations and standards.Key ResponsibilitiesDevelop and maintain regulatory...
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Global Regulatory Affairs Specialist II
2 weeks ago
Wilmslow, Cheshire, United Kingdom Waters Full timeOverviewThe 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...
