Hybrid Regulatory Affairs Professional, Medical Devices

at Sartorius

• Job title: Regulatory Affairs Professional, Medical Devices
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Gottingen, Germany

About the role

• Regulatory Affairs Professional creating clinical evaluation documents for medical devices in a fast-growing biotech company. Collaborating with stakeholders and ensuring compliance with regulations.

Responsibilities

• Prepare clinical evaluation documentation for Medical Devices (MDs), performance evaluation documentation for In Vitro Diagnostics (IVDs) and documents required for Post-Market Surveillance (PMS) of MDs and IVDs
• Create and maintain schedules and ensure their regulatory compliance
• Monitor market and regulatory developments, perform research and evaluate findings
• Conduct risk assessments and initiate appropriate corrective actions in response to incidents
• Continuously analyze new regulatory requirements and plan and implement resulting activities
• Advise internal stakeholders on regulatory changes, requirements and applicable standards
• Communicate with regulatory authorities and submit required documentation
• Assess the regulatory impact of changes (e.g., product changes)
• Develop and implement processes to meet regulatory requirements
• Draft procedures and work instructions and oversee monitoring to ensure compliance with regulatory processes and workflows

Requirements

• Master’s degree in natural sciences, medical technology, biotechnology or a comparable field
• Initial professional experience in Regulatory Affairs for Medical Devices and/or In Vitro Diagnostics
• Proven experience in scientific writing, particularly for Post-Market Surveillance and clinical documentation
• Knowledge of interpreting regulations, directives and declarations of principles, and experience working with relevant regulatory authorities
• Excellent organizational skills and the ability to set priorities
• Strong analytical skills and solid grounding in scientific principles
• Assertiveness, resilience, good interpersonal sensitivity, clear communication and people-management aptitude
• Fluent written and spoken German and English

Benefits

• Personal and professional development: mentoring, leadership programs, Talent Talks, internal seminars and coaching for managers
• Work–life balance: remote options, flexible working hours, flextime and sabbatical opportunities
• Attractive compensation: vacation and holiday bonuses, pension benefits, 35-hour work week and 30 vacation days
• Large, modern campus: open-plan offices, terraces, company restaurant with vegetarian and vegan options, Italian bistro with ice cream, on-site fitness studio and daycare
• Immediate impact: comprehensive onboarding including a virtual platform before your start, Welcome Workshops and a dedicated buddy as a contact person
• Inclusive culture: mutual support, team spirit and international collaboration; internal communities on topics such as coaching, agile working and a business women's network