Are you a top-performing Regulatory Affairs and Quality Assurance professional with experience in Class II medical devices? Are you ready for the opportunity to lead RA & QA at a venture-backed startup with award winning medical software and hardware? We’d love for you to take a look at Eko.
Eko is looking for an exceptional Head of Regulatory Affairs and Quality Assurance to join our executive team. As Head of RA & QA, you will report directly to Eko's CEO and be responsible for ensuring that the company’s quality system meets all regulatory requirements including FDA CFR Part 820, MDD 93/42/EEC, Canadian CMDCAS, and ISO 13485. This role also is responsible for leading all Regulatory Agency external audits. The manager is responsible for ensuring that products and their labeling meet all regulatory requirements (national and international).
This position is based in our Berkeley, CA headquarters. We offer a competitive compensation package.
- Manage and maintain compliance with FDA CFR Part 820 (including company registration and product submissions)
- Manage and maintain certification of ISO 13485 requirements (including leading Surveillance and Recertification Audits)
- Manage and maintain CE marking of products in compliance with MDD 93/42/EEC (including assembling and revising Technical Files and Device Master Records)
- Responsible for the CAPA system including owning and driving the investigation, root cause analysis, corrective action implementation, and verification of effectiveness for timely closures of CAPAs
- Responsible for the customer complaint system (including returned good and complaint investigations), trending complaint data, and reporting at Management Review
- Responsible for working with R&D and manufacturing to develop validation protocols for production processes
- Lead Auditor on site for all external and internal audits (including conducting internal audits, managing external audit schedules, directly facing auditors during Regulatory Agency audits, and corresponding with Regulatory Agencies on audit findings and closure)
- Ensure compliance of product labeling and marketing materials
- Responsible for Supplier Qualification, supplier audits, and managing the Approved Supplier List
- Responsible for Document Control and processing all document change requests
- Responsible for leading and conducting Management Review including trending, metrics, and objectives with collaboration and input from other departments
- Responsible for establishing the company quality objectives and quality plan on an annual basis
- Responsible for meeting regulatory requirements in foreign countries for registration of Eko products (including preparing country registration documents)
- Work in a consultative fashion with other department heads, such as marketing, production and operations as an advisor of technologies that may improve their efficiency and effectiveness
Critical Skills and Experience
- Minimum 4 years of Quality and Regulatory experience in the medical device industry
- Demonstrated knowledge of ISO 13485 and CFR Part 820 requirements
- Previous experience leading Regulatory Agency audits and directly facing external auditors
- Strong leadership skills, independent thinking, and passion for an exciting, fast-paced environment
- Ability to write standard operating procedures and work instructions