Global Regulatory Affairs Specialist (MDR/IVD)

Hologic, Inc.; San Diego (CA); On-site; USD 74,000 - 116,000; Full time

Job summary

Hologic, Inc. is seeking a Regulatory Affairs Specialist in San Diego to lead regulatory activities for Cytology and Molecular products. You will participate in cross-functional teams, assess changes for compliance, and prepare international submission dossiers.

This role requires a Bachelor's in life sciences or engineering with 4+ years in Regulatory Affairs, or a Master’s with RAC. You will collaborate with global authorities, maintain technical documentation, and ensure on-time submissions.

Qualifications

• Bachelor's Degree in life sciences or engineering with a minimum of 4 years direct experience in Regulatory Affairs (within an MDR / IVD industry preferred).
• Master’s Degree and/or RAC with a minimum of 1 year direct experience in Regulatory Affairs within the MDR / IVD Industry

Responsibilities

• Participate in product development project teams as regulatory representative and provide guidance on global regulatory requirements for new/existing products.
• Assess manufacturing process, design, and labeling changes regulatory assessments and global change management for manufacturing changes.
• Prepare and maintain international submission dossiers.
• Prepare, compile and publish post-market regulatory submissions.
• Compile and/or maintain Technical Documentations for IVD medical devices to support EU CE‑Mark.
• Interact with business partners to support ROW submissions for IVD medical devices (Asia Pacific, Latin America, Europe, the Middle East and Africa, Canada etc.).
• Monitor progress on key project deliverables and provide status updates to management on a regular basis.
• Review validation, clinical/R&D protocols and reports to be included or summarized in regulatory submissions.
• Interface with product development teams/sustaining teams and regulatory authorities throughout the product lifecycle.
• Provide recommendations for compliant advertising/promotional materials.
• Keep informed of new and revised regulations; disseminate information as appropriate.
• Manage relationships with international customers (e.g., regulatory agencies, distributors, etc.).
• Demonstrate in-depth understanding of advanced technical/scientific principles related to MDR / IVD reagent chemistry, laboratory automation, and software components of MDR / IVD medical devices
• Prepare/manage internal procedures for continuous process improvement. Provide guidance on new or revised procedures and policies (as assigned).

Skills

Regulatory coordination

Global regulation

Project management

Technical writing

Document control

Stakeholder communication

MDR/IVD knowledge

Education

Bachelor's Degree in life sciences or engineering

Master’s Degree and/or RAC

Tools

Agile

Oracle

Job description

Hologic, Inc. is seeking a Regulatory Affairs Specialist in San Diego to lead regulatory activities for Cytology and Molecular products. You will participate in cross-functional teams, assess changes for compliance, and prepare international submission dossiers.

This role requires a Bachelor's in life sciences or engineering with 4+ years in Regulatory Affairs, or a Master’s with RAC. You will collaborate with global authorities, maintain technical documentation, and ensure on-time submissions.