Global Scientific Affairs Manager (Hybrid – Remote)

SuperMicrobiologists; Deutschland; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

Hygiena is seeking a Global Scientific Affairs Manager to develop and deploy strategies for method certification, design validation studies, and support product commercialization. The role requires deep regulatory expertise and strong communication across international authorities and industry partners.

The candidate will represent Hygiena in scientific committees and conferences, monitor regulatory trends, and travel up to 30% to support global activities.

Qualifications

• Master’s or Ph.D. in Microbiology, Food Science, Analytical Sciences, Biotechnology, or related field.
• Minimum 5 years of experience in scientific or regulatory affairs or method validation in food safety.
• Deep knowledge of ISO 16140, AOAC validation studies, and regulatory frameworks.
• Strong ability to translate complex scientific data into regulatory submissions.
• Excellent written and verbal English communication; able to travel up to 30%.

Responsibilities

• Develop and deploy global strategies for method certification and recognition across product lifecycle.
• Define study designs and scopes per standards and regulatory guidance.
• Create validation procedures to support product commercialization processes.
• Build relationships with regulatory authorities and industry partners.
• Provide scientific and regulatory support to promote validation acceptance.
• Represent Hygiena in committees, standardization groups, and conferences; engage with AOAC, ISO, and national committees.
• Monitor regulatory trends and emerging scientific needs.

Skills

Regulatory affairs

Scientific affairs

Stakeholder engagement

Regulatory strategy

Communication skills

Data interpretation

Education

Master’s or Ph.D. in Microbiology/related field

Tools

ISO 16140

AOAC validation studies

Job description

Global Scientific Affairs Manager (Hybrid – Remote)

YOUR TASKS – BECOME A GAME CHANGER

• Develop and deploy global strategies for method certification and recognition for new product
  development, product improvement, modification, and scope extension
• Define method application scopes and study designs in accordance with standards, guidance documents, and applicable technical regulations
• Develop and ensure procedures for validation approvals to support and improve Hygiena’s Product Commercialization Process (PCP)
• Build and maintain relationships with regulatory authorities; act as liaison between Hygiena, regulatory agencies, and industry partners
• Provide scientific evidence and regulatory support to promote validation acceptance in national regulations and customer facilities
• Represent Hygiena in scientific committees, standardization working groups, and regulatory meetings; present at industry conferences; engage with AOAC International, ISO, and national committees
• Monitor regulatory trends, developments, and emerging scientific needs

YOUR PROFIL – WHAT MAKES YOU SPECIAL

• Master’s or Ph.D. in Microbiology, Food Science, Analytical Sciences, Biotechnology, or related field
• Minimum 5 years of experience in scientific affairs, regulatory affairs, or method validation in food safety, water microbiology or analytical testing industries
• Deep knowledge of ISO 16140, AOAC validation studies, food safety and quality regulations
• Strong capability in translating complex scientific data
• Strong networking, stakeholder engagement, and relationship-building skills
• Exceptional written and verbal communication skills with a proven ability to engage technical
• Demonstrated strategic thinking, analytical capabilities, and problem-solving skills
• Highly self-motivated and adaptable in a fast-paced, matrixed organization
• Excellent verbal and written communication in English
• Able to travel up to 30%