Director, Quality and Regulatory Affairs

 

Capnia, Inc. is a privately-held company based in Palo Alto, CA focused on the development of medical products to meet significant unmet needs. The Director, Quality and Regulatory Affairs will report to the President and Chief Operating Officer and will be responsible for all quality and regulatory aspects related to the design, development, manufacturing, registration, and commercialization of Capnia’s products.

 

Responsibilities include:

• Develop, implement, and maintain all aspects of an effective quality management system that meets the requirements of the Food and Drug Administration, ISO 13485:2003, the EU Medical Device Directive, the EU In Vitro Diagnostic Device Directive, the Canadian Medical Device Regulations, and all other applicable standards
• Working closely with Engineering and Manufacturing, ensure that products are designed, developed, and manufactured in accordance with internal procedures and meet the requirements set forth in the application regulations and standards
• Develop and monitor compliance with Quality Agreements with suppliers and contract manufacturers; conduct vendor selection and annual audits of suppliers and contract manufacturers as well as internal audits to monitor the effectiveness of the quality management system
• Act as primary liaison with regulatory agencies and certifying bodies for all regulatory submissions, responses to inquiries, site inspections and all matters regarding compliance with quality system requirements and product complaints/problems
• Plan and prepare all US and International regulatory submissions
• Develop and implement regulatory strategies based on US, EU and other International standards, regulations, legislation, and guidance
• Coordinate the review of product labeling and advertising including, but not limited to, marketing promotional materials

 

Requirements / Qualifications:

 

• Bachelor’s Degree in a scientific discipline or engineering
• Minimum of 10 years regulatory affairs experience, with at least 5 years experience with medical devices
• Demonstrated experience in Quality System Regulation Compliance, clearance of 510(k) and PMAs, and CE Marking of Class I and II medical devices
• Strong working knowledge of US and EU medical device regulations / legislation and applicable international standards including ISO 13485
• Experience directly interacting with US and International Health Authorities
• Proven track record with Part 11 compliance and software design verification / validation is critical
• Proficient in MS Office programs (i.e., Word, Excel, PowerPoint), Visio, and MS Project; experience with document templates and scientific reference software is desirable
• Must be detail-oriented with strong written and oral communication skills
• US and International travel may be required

 

To apply for this position, please send your resume to info@capnia.com.

Direct inquiries only, please.