Global Regulatory Strategy Lead - Medical Devices

Meridian Bioscience International Limited; North Billerica (MA); On-site; USD 145,000 - 185,000; Full time

Job summary

Meridian Bioscience International Limited is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies across global product lifecycles. You will oversee submissions, technical documentation, post-market surveillance, and field actions, collaborating with R&D, Quality, Marketing and Manufacturing teams to ensure compliant registrations and lifecycle management.

The ideal candidate brings 10+ years of regulatory affairs experience in medical devices or diagnostics, strong

Qualifications

• Bachelor of Science in Biology, Biochemistry, Microbiology or related field required.
• Advanced degree and/or Regulatory Affairs Certification preferred.
• Experience with FDA and ISO regulated environments including risk management (ISO 14971).
• Experience with design, development, and clearance of medical devices.

Responsibilities

• Provide regulatory leadership and strategic oversight for global registrations, lifecycle management, and field actions.
• Lead regulatory submissions and maintain technical documentation (DHF, regulatory dossiers).
• Oversee post-market surveillance, adverse event reporting, and vigilance activities.
• Lead post-market risk assessments and field actions communications with authorities and internal teams.

Skills

Regulatory affairs

FDA submissions

ISO 13485

Medical devices

Post-market surveillance

Risk management

Leadership

Cross-functional collaboration

Regulatory strategy

Documentation

Education

Bachelor's degree in Biology/Biochemistry/Microbiology

Advanced degree or RA Certification preferred

Tools

MS Office

Outlook

Excel

Job description

Meridian Bioscience International Limited is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies across global product lifecycles. You will oversee submissions, technical documentation, post-market surveillance, and field actions, collaborating with R&D, Quality, Marketing and Manufacturing teams to ensure compliant registrations and lifecycle management.

The ideal candidate brings 10+ years of regulatory affairs experience in medical devices or diagnostics, strong