Senior Director of Quality and Regulatory Affairs
2 months ago
We are seeking a highly experienced and skilled Senior Director of Quality, Regulatory and Clinical Affairs to lead our Global Design Quality Assurance, Regulatory & Clinical Affairs functions for our Clinical Business Unit. This role will be responsible for developing and implementing global regulatory strategies, managing regulatory affairs activities, and ensuring compliance with applicable regulations and standards.
Key Responsibilities- Strategic Leadership: Develop and implement global regulatory strategies to ensure compliance with applicable regulations and standards.
- Regulatory Affairs Management: Manage and conduct regulatory affairs activities, including those related to new product development, change management, post-market activities, and potential adverse events.
- Quality Assurance: Lead and manage Clinical Design Quality Assurance, provide solution-based decision making, and drive continuous improvement.
- Team Management: Manage and grow the teams, providing direction and leadership, ensuring that company objectives and regulatory requirements are met in the most efficient manner possible.
- External Influence: Interact with regulatory bodies, registration authorities, and other external stakeholders to ensure timely and effective submissions.
- Education: Minimum of an Advanced degree (PhD, in a Life Science, MBA or equivalent)
- Experience: Proven extensive regulatory affairs experience with medical devices, IVD experience essential
- Skills: Extensive and proven understanding of FDA and global regulations, including China, Europe (IVDR), India, and Brazil; significant managerial experience, including across multiple locations; good business acumen and collaboration skills
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Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob SummaryThis role is responsible for leading the global design quality assurance, regulatory, and clinical affairs functions for Waters Clinical Business Unit. The ideal candidate will have extensive experience in regulatory affairs, particularly in medical devices and in-vitro diagnostics, and will be able to develop and implement global regulatory...
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Director of Clinical and Regulatory Operations
2 months ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Director of Quality, Regulatory and Clinical Affairs to lead our Global Design Quality Assurance, Regulatory & Clinical Affairs functions for our Clinical Business Unit. This role will be responsible for developing and implementing global regulatory strategies, managing regulatory affairs...
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Director of Clinical and Regulatory Operations
2 months ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Director of Quality, Regulatory and Clinical Affairs to lead our Global Design Quality Assurance, Regulatory & Clinical Affairs functions for our Clinical Business Unit. This role will be responsible for developing and implementing global regulatory strategies, managing regulatory affairs...
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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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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
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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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
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
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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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 months ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full time{"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...
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Regulatory Affairs Specialist II
2 months ago
Wilmslow, Cheshire East, United Kingdom Waters Corporation Full time{"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...
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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...