Quality Assurance Manager

Key Responsibilities:

1. Develop and implement quality management systems (QMS) compliant with ISO 13485 and FDA regulations

2. Conduct audits and inspections to ensure compliance with quality standards.

3. Manage corrective and preventive actions (CAPA) and implement quality improvements.

4. Get all the compliance, licensing, audits done under his responsibility.

Regulatory Affairs:

1. Ensure compliance with regulatory requirements for medical devices, including FDA, CE, and other relevant regulations.

2. Manage regulatory submissions

3. Monitor and analyze regulatory changes and updates, and implement necessary changes.

4. Collaborate with teams to ensure labeling and advertising compliance.

Requirements:

1. Bachelor's degree in a relevant field (e.g., engineering, science).

2. Experience in quality assurance and regulatory affairs in the medical device industry.

3. Experience with calibration, validation, SOP, BMR, MFR, QMS standards (ISO 13485) and regulatory requirements (FDA, CE).

4. Strong analytical and problem-solving skills.

• 5. Excellent communication and leadership skills.