Regulatory Affairs Specialist

Position: Regulatory Affairs Specialist

Qualifications

Preferable:

• Bachelors or Masters degree in Biomedical Engineering

Desirable:

• Masters 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

1. Determining the appropriate risk class (Class I, II, or III) of a device, which directly influences the level of regulatory scrutiny required.
2. 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).
3. Identifying applicable guidelines and monitoring compliance.
4. Performing EUDAMED registration.
5. Drafting Instructions for Use (IFU), labels, implant cards, and other applicable information materials.
6. Ensuring awareness of UDI requirements and related processes.
7. 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)

1. Supporting international product registration in various countries.