Global Regulatory Affairs Specialist II

TN United Kingdom; Wilmslow; On-site; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Global Regulatory Affairs Specialist II to lead regulatory initiatives for innovative products. This role involves guiding development teams, ensuring compliance with international regulations, and managing regulatory filings. The ideal candidate will possess a strong background in regulatory affairs within the In Vitro Diagnostic Medical Device sector, showcasing expertise in navigating complex regulatory landscapes. Join a dynamic team where your contributions will directly influence product development and market success, all while collaborating with diverse teams across the globe.

Qualifications

• Bachelor’s degree in a relevant field required.
• Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment.

Responsibilities

• Lead regulatory affairs for new product development projects.
• Provide regulatory guidance on changes to existing products.
• Support post-market surveillance and vigilance activities.

Skills

Regulatory Affairs

Analytical Chemistry

Biochemistry

Biomedical Engineering

Technical Writing

Critical Thinking

Active Listening

Effective Communication

Education

Bachelor's degree in Analytical Chemistry, Biochemistry, or Biomedical Engineering

Graduate education (preferable)

Job description

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Global Regulatory Affairs Specialist II, Wilmslow

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Client:

Waters Corporation

Location:

Wilmslow, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

3774d8aa5211

Job Views:

13

Posted:

28.04.2025

Expiry Date:

12.06.2025

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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