Quality Assurance and Regulatory Compliance Director

We are looking for a goal oriented, motivated, team player with plenty of initiative. We offer an exciting and innovative work environment, excellent benefits, very satisfying compensation and the opportunity to make a difference.

Please read the description below and if it sounds like a good fit, email your resume and follow up with a phone call!

Quality Assurance and Regulatory Compliance Director

Responsibilities include:

• Managing the development, implementation and maintenance of quality assurance systems and activities. 
• Ensures regulatory requirements are met.
• Oversees generation and review of documents used in Good Manufacturing Practices.
• Manages all aspects of product quality and compliance with Federal and International Regulatory requirements.  

Essential Duties and Responsibilities:

• Serves as Management Representative for the Company's San Diego facility.
• Ensures that the Quality Management System is established, implemented and maintains it's effectiveness in accordance with applicable standards.
• Ensures customer and regulatory requirements are determined and met.
• Responsible for regulatory functions including planning and filing of documentation with domestic and international agencies, compliance with regulatory requirements and ensuring customer requirements are met.
• Supports the preparation of 510k, PMA's or IDE's for FDA on new or substantially changed products.
• Prepares and submits dossiers to Notified Body in the European Union for review and approval. Prepares Technical files as required.
• Reviews and approves all Engineering changes for regulatory impact for FDA, Notified Body in the EU, Canada, Japan and ROW.
• Manages the Internal Audit program in compliance with QSR, ISO 13485:2003 and CMDR requirements, and performs internal audits as required.
• Reviews, approves and oversees Complaint Investigation process to ensure thorough and timely investigation closure.
• Direct the Quality Assurance functions to assure that all products manufactured meet customer, corporate, quality and regulatory requirements.
• Responsible for assuring that corrective actions are established and that root cause elimination is completed for identified issues.
• Maintains an expertise in FDA/GMP, ISO 13485:2003/MDD, the Canadian Medical Devices Regulations (CMDR), and other international requirements.
• Ensures that all product, process and labeling changes are properly reviewed for regulatory impact.
• Responsible for reporting Quality metrics including, Corrective and Preventive Action status, internal audit results, Return Goods activities through Quality Management Reviews.
• Directs the activities of the documentation function.  Responsible for the efficient control of all documentation required by regulatory agencies and internal customers.
• Responsible for ensuring that internal audits are scheduled, performed and followed up. 
• Develop and implement budgets and organizational structures that are efficient and effective in supporting the above activities.
• Responsible for the process, handling and disposition of non-conforming and internal material.
• Practices and promotes Good Manufacturing Practices.
• Thorough knowledge and understanding of domestic and international quality system and regulatory approval processes. 

Education/Skills/Experience:

• Requires a Bachelors/Masters degree in engineering biological or physical science.
• Minimum 10 years experience in Quality Assurance/Quality control functions.
• Directly related experience in the medical device manufacturing industry.

We are committed to creating an environment where all employees are valued and respected. We offer a competitive compensation/benefits package including 401(K) savings plan with match, medical, vision, dental, life insurance, tuition reimbursement and employee stock purchase plan.