ÂÜÀòÂÒÂ×

As part of Penumbra’s legal and compliance team, you will support a growing and dynamic company that develops ground-breaking technology to further its mission of saving patients’ lives. You will be responsible for leading the operational aspects of the company’s legal compliance program, which include ensuring that as Penumbra continues to grow and evolve as an organization, it always has in place the infrastructure and programs necessary to meet statutory and regulatory requirements applicable to its business, including those relating to global anti-kickback and anti-corruption laws, and transparency reporting.

What You’ll Work On: • Lead compliance team operations and functions, including drafting and reviewing policies and procedures, performing regular risk assessments, and conducting audits and investigations. * • Review and revise current compliance team initiatives, programs, and operations, and implement and execute appropriate, risk-based updates to those. * • Continually monitor and advise management of potential compliance risk areas.* • Advise, collaborate with, and support global operations and functions (including sales, marketing, vendor/supplier management and finance) on compliance matters to ensure adherence with laws, regulations, standards, guidelines, and Penumbra’s Code of Conduct. * • Support training programs for personnel on compliance and ethics topics. • Lead anti-bribery/anti-corruption program related to third parties, including distributors, regulatory agents, and strategic partners. * • Oversee compliance program for risks related to interactions with healthcare professionals. * • Manage outside counsel and consultants as needed to fulfill the Company’s compliance function. • Develop strong relationships across departments and with senior management to maintain open lines of communication and support a culture of compliance. * • Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. * • Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. * • Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. * • Ensure other members of the department follow the QMS, regulations, standards, and procedures. * • Perform other work-related duties as assigned. *Indicates an essential function of the role.

What You’ll Bring: • Bachelor’s degree with 8+ years of experience, or equivalent combination of education and experience. Additional qualifications: • Medical device, pharmaceutical, biotech, or other regulated industry experience desired • In-depth knowledge and understanding of applicable regulatory and compliance requirements for companies in the life sciences preferred; strong preference for international compliance experience • Experience with Fair Market Value assessments and methodology a plus • Experience with global transparency reporting requirements (e.g., U.S. Physician Payments Sunshine Act) a plus • 5 years of experience in a supervisory role desired • Strong oral, written, and interpersonal communication skills • High degree of accuracy and attention to detail • Proficiency with MS Word, Excel, and PowerPoint • Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

Working Conditions • General office environment • Willingness and ability to work on site. May have business travel from 5-10%. • Potential exposure to blood-borne pathogens • Must be able to move between buildings and floors. • Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. • Must be able to read, prepare emails, and produce documents and spreadsheets. • Must be able to move within the office and access file cabinets or supplies, as needed. • Must be able to communicate and exchange accurate information with employees at all levels on a daily basis. 

Alameda, CA

Starting Base Salary is $125,000/year - $200,000/year.    We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.