Human Xtensions is a rapidly growing startup, developing breakthrough technology in the field of robotic Minimally Invasive Surgery (MIS).
We are looking for a part time RA Specialist to join our core RA team.
Assist in all regulatory activities including regulatory submissions, registrations, PMS reporting, adverse event reporting. Assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. Assist in creation and maintenance of regulatory files.
Assistance and execution of regulatory tasks to enable timely access to market.
- Provide regulatory support and guidance for product development, and for product design and manufacturing changes.
- Coordinate efforts associated with the preparation of regulatory documents and/or submissions.
- Write and/or compile regulatory submissions in a format consistent with applicable guidance documents.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Monitor and communicate on new or changing regulatory requirements.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Regulatory support in the customer complaint handling.
- Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
- Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance.
- Perform other duties as assigned.
- Bachelor’s Degree required
- Minimum 2 years’ experience of regulatory affairs in medical devices
- Knowledge of FDA and EU regulations and guidance. Knowledge of other market requirements an advantage
- Knowledge of IEC 60601 standards a plus
- Excellent written and oral communication skills in English
- Ability to handle multiple tasks, self-motivated and be detail oriented