Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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