Position: Regulatory Affairs Specialist
Qualifications
Preferable:
- Bachelor's or Master's degree in Biomedical Engineering
Desirable:
- Master's degree in Pharmacy, Medical Devices, or Science
Experience
Preferable:
- 4 to 5 years of experience in Regulatory Affairs and Quality Assurance in cardiac implantable devices
Desirable:
- 4 to 5 years of experience in Regulatory Affairs and Quality Assurance in Class IIb and Class III implantable devices
Job Description
- Determining the appropriate risk class (Class I, II, or III) of a device, which directly influences the level of regulatory scrutiny required.
- Developing a strategic pathway for device approval or clearance in target markets (e.g., 510(k) clearance or PMA approval in the US, CE marking in the EU).
- Identifying applicable guidelines and monitoring compliance.
- Performing EUDAMED registration.
- Drafting Instructions for Use (IFU), labels, implant cards, and other applicable information materials.
- Ensuring awareness of UDI requirements and related processes.
- Drafting, compiling, reviewing, and updating technical files and QMS documents according to EU MDR requirements, including:
- Design & Development files
- Risk management documentation
- Preclinical evaluation reports
- Post-market surveillance documentation
- Information materials
- QMS documents (e.g., Quality Manual, SOPs, Work Instructions, Records, Validations/ Calibrations Plans, Protocols, and Reports)
- Supporting international product registration in various countries.
