Regulatory Affairs Manager Devices

hace 3 días


Tlahuac, México Artixio Consulting Pvt Ltd A tiempo completo

**Regulatory Affairs Manager (Medical Devices) - Mexico Position**

**Overview**:
**Responsibilities**:

- **Medical Device Registration**:

- Lead the registration process for medical devices with **COFEPRIS**.
- Determine the appropriate classification of devices based on the risk-based system.
- Prepare and compile all necessary documentation, including technical specifications, clinical data, labeling, and quality management system evidence.
- **License Transfer**:

- Facilitate license transfer processes for medical devices.
- Coordinate with relevant authorities and stakeholders to ensure seamless transitions.
- Maintain compliance during license transfers.
- **Project Management**:

- Manage multiple projects simultaneously.
- Develop project plans, set milestones, and allocate resources effectively.
- Monitor progress, identify risks, and implement corrective actions.
- Collaborate with cross-functional teams to achieve project goals.
- **Leadership and Team Management**:

- Provide strategic guidance and mentorship to team members.
- Foster a collaborative and results-driven environment.
- Lead by example, demonstrating a commitment to excellence and adherence to timelines.

**Qualifications**:

- Bachelor’s degree in a relevant field (e.g., life sciences, engineering, regulatory affairs).
- **Minimum 5 years** of experience in medical device regulatory affairs in Mexico.
- In-depth knowledge of **COFEPRIS** regulations and registration processes.
- Experience with license transfers and familiarity with quality management systems (e.g., ISO 13485).
- Strong project management skills, including the ability to prioritize tasks and meet deadlines.
- Excellent communication and leadership abilities.

**Additional Information**:

- Location: Mexico City, On Site

If you are a proactive, detail-oriented professional with a passion for regulatory compliance and a track record of successful project management, we encourage you to apply Please submit your resume and a cover letter outlining your relevant experience and achievements.



**Job Types**: Full-time, Contract
Contract length: 12 months

**Salary**: $30,000.00 - $80,000.00 per month

**Experience**:

- Medical Device Regulatory Affairs: 5 years (required)

Application Deadline: 20/03/2024
Expected Start Date: 01/04/2024



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