Senior Regulatory Affairs Specialist, IVD

Kelly Science, Engineering, Technology & Telecom; California (MO); Remote; Full time

Job summary

A leading company in biotechnology seeks a Senior Regulatory Affairs Specialist for a full remote role. This position involves ensuring regulatory compliance for IVD products, collaborating with various teams, and managing product labeling changes. The ideal candidate will have a strong background in Regulatory Affairs and Quality Management Systems, with a focus on IVD diagnostics. This is a 12-month contract offering competitive pay.

Qualifications

• 5+ years of related work experience with a Bachelor's degree.
• Understanding of US-IVD and CE-IVDR regulations.

Responsibilities

• Complete regulatory reporting assessments for changes to products.
• Collaborate with cross-functional teams for regulatory compliance.

Skills

Regulatory Affairs

Quality Management Systems

Collaboration

Education

Bachelor’s degree

Master’s degree

Tools

Agile PLM

SAP ERP

Salesforce

Job description

Senior Regulatory Affairs Specialist, IVD

Senior Regulatory Affairs Specialist, IVD

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Kelly Science, Engineering, Technology & Telecom provided pay range

This range is provided by Kelly Science, Engineering, Technology & Telecom. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$47.00/hr - $50.00/hr

Direct message the job poster from Kelly Science, Engineering, Technology & Telecom

Senior Regulatory Affairs Specialist, IVD

Location: Full remote, based out of Sunnyvale, CA

Pay: $47/hr-$50/hr

12 month contract role

Overview:

The Regulatory Affairs Senior Specialist role includes completing regulatory reporting assessments for anticipated manufacturing, facility, product, and packaging changes to global regulatory agencies. The position collaborate with cross-functional teams (Technical Publications, Product Transfer, Quality, R&D, Clinical Affairs) on global change control processes and ensure regulatory compliance of product labeling.

Responsibilities:

• Familiarize with client's global change control process.
• Review and implement changes to product labeling/instructions for use.
• Partner with stakeholders to ensure accuracy of labeling changes.
• Collaborate with the Technical Publications team for regulatory compliance.

Requirements:

• Bachelor’s degree with 5+ years of related work experience OR Master’s degree with 3+ years of related work experience.
• Understanding of Regulatory Affairs concepts and regulations/guidelines governing the development of IVD diagnostic products.
• Knowledge of US-IVD, CE-IVDD, CE-IVDR governance for IVD diagnostic products.
• Familiarity with Quality Management System regulations/standards (21 CFR Part 820, EN ISO 13485).
• Experience with global registrations, regulatory dossiers, and working with core teams.

Preferred Requirements:

• Prior knowledge of Agile PLM system, SAP ERP system, and Salesforce-based applications.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology Research and Medical Equipment Manufacturing

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