Sr. Manager, Regulatory Affairs, Akura Medical

Akura Medical, a Shifamed Portfolio Company, is focused on a differentiated approach delivering an effective solution to address the major challenges of venous thromboembolism (VTE). Akura recently announced the first-in-human use of its mechanical thrombectomy platform. Each year VTE affects as many as 900,000 Americans, resulting in about 100,000 premature deaths. To learn more about Akura Medical, please visit www.akuramed.com.

ABOUT SHIFAMED

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description

The Sr. Manager, Regulatory Affairs champions the company's overall regulatory submission and approval efforts, ensures regulatory compliance within all markets in which company products are marketed. Major responsibilities include a leadership role in the research, development, and execution of regulatory strategies to support the timely approval of regulatory applications in support of the company's corporate objectives. Leads in ensuring that the Quality System is established, maintained, and periodically assessed for its performance and represents current regulatory standards. Represents the company to regulatory bodies and communicates formally and informally to those bodies in support of the company objectives. This is a full time on-site position and will require reporting to our offices located in Los Gatos, CA.

Responsibilities, Skills & Hands-On Experience

• Ensures promotion of awareness of regulatory and customer requirements throughout the organization.

• Facilitates regulatory body audits.

• Leads the execution of the regulatory submission and approval effort with strategic vision and sound strategies.

• Implements company regulatory strategies for the development of new products and product enhancements to achieve marketable products in an efficient and effective manner. Personally, directs the assembly of all components of regulatory applications.

• Maintains outstanding relationships with all key internal customers and regulatory agencies. Interacts with the FDA (and international regulatory agencies) on a proactive, independent, and frequent basis. Also interacts with any internal or external organizations involved with regulatory compliance.

• Oversees implementation of quality procedures and protocols that ensure compliance and product reliability.

• Reviews product development, bench testing, animal testing, quality assurance, manufacturing, quality system, marketing, and clinical research study reports and other regulatory documents.

• Evaluates external business development opportunities from a regulatory and scientific perspective and provides feedback.

• Manages Regulatory budgets for all submission activities.

• Staffs/manages Regulatory personnel, as applicable.

• Oversees the management of MDR/Vigilance reporting of company products.

• Ensures appropriate communication processes are established within and across functional groups.

• Hiring and supervisory responsibilities as the department develops.

Education & Work Experience

• Bachelor's in Engineering or Life Sciences and 10+ years of medical device industry experience, including 5+ years of technical management responsibilities.

• Previous experience in the development and execution of regulatory strategies leading to medical device market clearance/approval is required.

• Applied knowledge of FDA QSR, ISO 13485 and Medical Device Regulations are required.

• Regulatory Affairs Certification (RAC), MD or PhD desired.

• Excellent communications skills (both written and verbal) required.

• Excellent presentation skills are required.

• Ability to work independently or in team setting required.

• Ability to travel as needed.

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $150,000 to $180,000 + equity + benefits.

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.