Director / Manager of Quality & Regulatory Affairs at Caldera Medical in Agou...

Caldera Medical is a rapidly growing medical device company located in Agoura Hills, CA and is focused on designing, manufacturing, marketing and selling implantable grafts into the Gynecology, Urology and Urogynecology surgical markets.  To learn more about us, please visit us at www.calderamedical.com

Job Description

The ideal candidate will possess strong regulatory knowledge, good analytical skills, excellent communication skills, a collaborative style, the ability to influence quality both within and outside the organization and a strong focus on the customer.

• Manage complaint handling, medical device reporting, vigilance reporting, field actions, and label control.
• Maintain fiscal responsibility and budget compliance.

Regulatory

• Act as the technical expert for all regulations (FDA, CE, ISO, etc.) ensuring the proper processes, policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance.
• Monitor external regulatory developments, identify risks, and communicate potential issues to senior management.
• Manage relationships within the relevant regulatory agencies to improve quality of submissions and understand the impact of any pending or proposed regulatory changes.
• Assure all regulatory submissions are accurate and submitted in a timely manner.  Determine if regulatory submissions are required or if a memo-to-file is adequate.
• Educate/train company employees on regulatory matters to assure compliance with requirements.
• Assure all marketing, sales and other materials (e.g. labels) and practices are in conformance with regulatory requirements.
• Develop and maintain Material Safety Data Sheets (MSDS) database, as applicable.

Quality

• Work with engineering to evaluate and develop design and process improvements for product reliability issues and to improve overall reliability and quality of products.  Act as the primary liaison between management, engineering and vendors on reliability issues.
• Own the Supplier Quality Management Program.  Work with contract manufacturers and suppliers to improve quality through pre-qualification reviews, on-going oversight and audit, implementation of engineering changes and other procedures.
• Assure engineering design processes and manufacturing processes are conducted in compliance with the Corporate Quality Plan and ensure validation and testing protocols are robust.  Instill an emphasis on designing and testing for reliability within the manufacturing and development activities.  Ensure FDA, ISO, and other regulatory requirements are met.
• Generate reports, utilizing statistics, as appropriate, to evaluate trends and to aid management in the identification and resolution of issues and overall quality improvement effort.  Recommend KPI’s to measure compliance with quality standards and effectiveness of corrective actions across all functions.
• Assure control and proper disposition of nonconforming products and corrective actions.
• Maintain Corrective & Preventive Action (CAPA) process and ensure timely follow-up, and implementation of corrective actions.
• Conduct Quality System Audits (including international audits) and assure corrective action is performed.
• Maintain and update, as necessary, the Corporate Quality Plan, develop and deliver training to ensure organization understands and embraces quality procedures and verify on-going compliance with quality procedures.
• Assure all team members are trained in the Quality System.

Education and Experience:

• B.S. in Regulatory Affairs and microbiology or biology strongly preferred.  Equivalent work experience will be considered.
• 15 or more years experience in some combination of Regulatory and Quality roles, some portion of which must include a manufacturing environment and medical devices, with at least 10 years in Quality function and at least 5 years with regulatory responsibilities.
• Proven ability to create the Quality and regulatory strategies for an organization and experience lead others to achieve the related goals.
• Extensive knowledge of:  FDA (including GMP), CE, and ISO strongly preferred.
• Experience with some medical devices.   Implant experience preferred.
• A proven ability to deliver value in the following areas: supplier quality audits/improvement plans, reliability engineering, fault analysis and troubleshooting, corrective action tracking and quality management training.
• Strong track record of collaborative working relationship with FDA and ISO which has led to successful outcomes for the business.  FDA on-site audit experience preferred.
• Experience with statistical analysis (software) preferred and ability to synthesize data from various sources to identify trends required.
• Ability to manage and report on projects and drive them to conclusion.
• Strong communication skills - able to challenge, influence, and articulate a view and drive behavior or action and train employees.
• Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
• Adaptability and resourcefulness to roll-up-sleeves and multi-task in order to thrive in small company environment.

This position offers the opportunity to work at a senior level in the organization, with unique technologies, in a fast-paced setting and have a significant visibility and impact on the business.  There will be some travel in the position, primarily to suppliers, possibly to customers and sales representatives.