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Global Regulatory Affairs Specialist II, Wexford
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Client:
Waters Corporation
Location:
Wexford, Ireland
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
eb53fa7dc080
Job Views:
3
Posted:
03.06.2025
Expiry Date:
18.07.2025
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Job Description:
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 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
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