RA/QA Consultant Medical Device

Junior Consultant - QA/RA
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.
Key Responsibilities:
Regulatory Submissions:
Prepare and submit regulatory documents to authorities, ensuring compliance with national and international regulations.
Technical Documentation:
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.
Post-Market Surveillance:
Conduct post-market surveillance activities, including adverse event reporting and PMS reports.
Validation Testing:
Participate in the planning and execution of validation tests, ensuring accurate and reliable results.
CER Preparation:
Assist in the preparation and maintenance of Clinical Evaluation Reports (CER).
Regulatory Strategy:
Support the development of regulatory strategies for new products and market entries.
Stakeholder Communication:
Liaise with internal and external stakeholders, including regulatory bodies, to address queries and provide regulatory guidance.
Key Qualifications:
2-5 years of Regulatory Affairs experience
Practical experience in Regulatory processes
Experience from smaller companies is preferred
Multilingual proficiency in European languages such as German, French, or Italian is a plus
Benefits:
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
Why Join Us:
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
About Us:
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.