Regulatory Affairs Consultant with| German
1 week ago
Position Overview:
We are seeking a motivated Junior Consultant with 2-5 years of experience in Regulatory Affairs.
This role requires hands-on involvement with the management of technical files, post-market regulatory activities, global device registration, and formulating regulatory strategies.
Quality Assurance experience is an added advantage.Regulatory Submissions:
Prepare and submit regulatory documents to authorities, ensuring compliance with national and international regulations.
Create, review, and manage technical files and documentation for medical devices.
Compliance Monitoring:
Monitor and interpret regulatory requirements, ensuring that company products and practices are in compliance with relevant regulations and standards.
Validation Testing:
Participate in the planning and execution of validation tests, ensuring accurate and reliable results.
Regulatory Strategy:
Support the development of regulatory strategies for new products and market entries.
Liaise with internal and external stakeholders, including regulatory bodies, to address queries and provide regulatory guidance.
2-5 years of Regulatory Affairs experience
~ Practical experience in Regulatory processes
~ Multilingual proficiency in European languages such as German, French, or Italian is a plus
Hybrid work model:
Minimum 3 days in-office with a 4-day work week (Fridays off)
Opportunities for professional growth with potential to rise to partner level
Engaging training programs
Rapidly expanding business with new, significant projects on the horizon
Exposure to diverse and exciting projects
Collaborative, diverse, and flexible work culture
Potential expansion into the pharmaceutical market
We are a specialized consultancy providing Regulatory Affairs support to the medical device industry. Our expertise spans across ISO 13485, European regulations, FDA regulations, and other global standards for medical devices.
Join our team and be part of a growing consultancy where your contributions will drive success and innovation in the medical device industry.
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