About The Position
This role specializes in the creation and maintenance of Instructions for Use (IFUs), risk management files, and technical files, ensuring compliance with applicable global regulations and standards. This position requires a strong understanding of regulatory requirements and a meticulous approach to documentation.
- IFU Management: Develop, write, and maintain |(including printing &translation management ) IFUs for legacy devices, ensuring accuracy, clarity, and compliance with relevant regulations and standards (e.g., MDR, 21 CFR Part 801). Manage the IFU lifecycle, including revisions, approvals, and distribution.
- Risk Management File Maintenance: Maintain and update risk management files, ensuring compliance with ISO 14971. Collaborate with cross-functional teams to identify hazards, assess risks, and implement risk controls.
- Technical File Maintenance: Compile and maintain technical files for legacy devices, ensuring all required documentation is complete, accurate, and readily accessible for regulatory submissions and audits.
- Regulatory Submissions: Support the preparation and submission of regulatory documents, as needed.
- Regulatory Compliance: Monitor and interpret relevant regulations and guidance documents, ensuring ongoing compliance.
- Collaboration: Work closely with cross-functional teams (e.g., engineering, product management, marketing) to gather information and ensure alignment on regulatory requirements.
- Communication: Communicate effectively with internal stakeholders and external regulatory agencies, as needed.
- Audits: Support internal and external audits
- Continuous Improvement: Contribute to the continuous improvement of regulatory processes and procedures.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related field.
- Minimum of 3 years of experience in regulatory affairs within the medical device industry.
- Experience in successfully writing and maintaining IFUs, risk management files, and technical files.
- Experience with regulatory submissions for medical devices is a plus.
- Experience with translation handling is a strong advantage.
- Certification in regulatory affairs (e.g., RAC) is preferred.
- Experience with eIFU as an advantage
- Experience with class IIb HW&SW product strong advantage
- Strong knowledge of global medical device regulations and standards: Including but not limited to MDR, 21 CFR Part 820, ISO 13485, ISO 14971, and other relevant regulations.
- Experience in writing and maintaining IFUs for medical devices.
- Expertise in risk management for medical devices.
- Experience in compiling and maintaining technical files for medical devices.
- Excellent writing and communication skills: Ability to clearly and concisely communicate complex technical information.
- Strong attention to detail and organizational skills: Ability to manage multiple projects and meet deadlines.
- Ability to work independently and as part of a team.
- Ability to prioritize
- Proficiency in using document management systems and other relevant software tools.
- Fluency in English (written and spoken) is essential. Additional languages are a plus.