Regulatory Affairs Specialist II
2 months ago
{"Responsibilities": {"New Product Development": ["Lead regulatory affairs for new product development projects, providing 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 labeling 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 materials"], "Post 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 products"]}, "Skills": ["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"]}
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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
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
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
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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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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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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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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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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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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Global Regulatory Affairs Specialist II
2 weeks ago
Wilmslow, Cheshire East, United Kingdom Waters Full timeJob SummaryThe 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 ResponsibilitiesNew Product...
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Regulatory Affairs Specialist II
2 months ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeAbout the RoleWaters Corporation is seeking a highly skilled 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 projects.ResponsibilitiesDevelop and maintain regulatory strategies for new and modified...
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Regulatory Affairs Specialist II
2 months ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeAbout the RoleWaters Corporation is seeking a highly skilled 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 projects.ResponsibilitiesDevelop and maintain regulatory strategies for new and modified...
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Regulatory Affairs Lead II
2 months ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeAbout the RoleWaters Corporation is seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory guidance and support for new product development projects.ResponsibilitiesDevelop and maintain regulatory strategies for new and modified...
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Regulatory Affairs Lead II
2 months ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeAbout the RoleWaters Corporation is seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory guidance and support for new product development projects.ResponsibilitiesDevelop and maintain regulatory strategies for new and modified...
