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Global Regulatory Affairs Specialist II, Wexford
Client:
Waters Corporation
Location:
Wexford, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
eb53fa7dc080
Job Views:
4
Posted:
19.04.2025
Expiry Date:
03.06.2025
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.
* Perform 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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