Senior Regulatory Affairs Leader: Global Compliance

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

Job summary

Meridian Bioscience International Limited in the United States seeks a Principal Regulatory Affairs Specialist to lead regulatory strategy across the product lifecycle, overseeing submissions, compliance, and post-market activities. This senior role partners with R&D, manufacturing, QA, and marketing to ensure global registrations, risk management, field actions, and regulatory excellence.

The ideal candidate has at least 10 years in regulatory affairs, deep knowledge of FDA and ISO

Qualifications

• Bachelor's degree in Biology, Biochemistry, Microbiology or related field.
• Advance degree and/or Regulatory Affairs Certification preferred.
• Minimum of 10 years of direct Regulatory Affairs experience.

Responsibilities

• Develop and execute global regulatory strategies across the product lifecycle.
• Lead regulatory submissions, technical documentation, and regulatory dossiers.
• Provide regulatory oversight for post-market surveillance, field actions, and vigilance.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory compliance

Education

Bachelor of Science in Biology/Biochemistry/Microbiology

Regulatory Affairs Certification (RAC) preferred

Tools

MS Office

Job description

Meridian Bioscience International Limited in the United States seeks a Principal Regulatory Affairs Specialist to lead regulatory strategy across the product lifecycle, overseeing submissions, compliance, and post-market activities. This senior role partners with R&D, manufacturing, QA, and marketing to ensure global registrations, risk management, field actions, and regulatory excellence.

The ideal candidate has at least 10 years in regulatory affairs, deep knowledge of FDA and ISO