QA and RA Officer

Quality Assurance:

1. Ensure compliance with quality management systems and standards, such as ISO 13485 and Good Manufacturing Practices (GMP).

2. Perform the 'buy off' process as part of the quality assurance scope.

3. Monitor process technician for proper procedure compliance (Need to know how to do).

4. Perform Biomechanical, Product Failure and Reject Analysis test.

5. To inspect the raw materials coming in from vendors and reporting deficiencies as if discovered.

6. To analyse deficient products and determine the root cause.

Regulatory Compliance: Ensure compliance with all relevant regulations, laws, and guidelines pertaining to [industry/sector] products/services in various jurisdictions.

Documentation Management: Develop and maintain regulatory documentation, including product registrations, submissions, dossiers, and technical files.

Regulatory Strategy: Collaborate with cross-functional teams to develop and execute regulatory strategies, including product approvals, licensing, and post-market surveillance.

Risk Assessment: Conduct risk assessments to identify potential regulatory issues and provide recommendations to mitigate risks.

Regulatory Intelligence: Stay up-to-date with regulatory developments, changes, and trends in the medical devices landscape and communicate their impact to relevant stakeholders.

Interdepartmental Collaboration: Collaborate with cross-functional teams, including R&D, quality assurance, clinical affairs, and marketing, to ensure regulatory requirements are met throughout the product lifecycle.

Audits and Inspections: Assist in internal and external audits and inspections to ensure regulatory compliance and address any findings or deficiencies.

Training and Education: Provide training and guidance to internal stakeholders on regulatory requirements, policies, and procedures.