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.

What We Offer

•A collaborative teamwork environment where learning is constant, and performance is rewarded.

•The opportunity to be part of the team that is revolutionizing the treatment of some of the world’s most devastating diseases.

•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra’s Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra’s AAP Policy Statement.

Legal Compliance Officer

Penumbra Inc

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