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Legal Compliance Officer

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.

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Average salary estimate

$162500 / YEARLY (est.)
min
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$125000K
$200000K

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What You Should Know About Legal Compliance Officer, Penumbra

As a Legal Compliance Officer at Penumbra, Inc., located in the vibrant city of Alameda, CA, you will play a crucial role in ensuring that our innovative healthcare solutions not only save lives but also adhere to the highest legal and ethical standards. You'll lead a dynamic compliance team responsible for developing and refining our compliance program to meet statutory and regulatory requirements worldwide. This includes navigating the complexities of global anti-kickback and anti-corruption laws, as well as transparency reporting. Your days will be filled with various responsibilities, like drafting and reviewing essential policies, conducting risk assessments, and performing audits that safeguard our values and operations. You’ll collaborate closely with departments like sales and marketing, ensuring everyone is aligned with compliance matters while fostering a culture of ethics and integrity within Penumbra. With your leadership, you'll support training initiatives that empower employees to understand compliance effectively. Moreover, you’ll work hand-in-hand with outside counsel and external consultants to enhance our compliance functions. Your ability to build strong relationships across various teams will be invaluable, as you guide the company in adapting to changing regulations. If you bring a wealth of knowledge from the medical device, pharmaceutical, or biotech industries, along with at least eight years of relevant experience, consider joining our mission to revolutionize patient care while upholding our commitment to compliance!

Frequently Asked Questions (FAQs) for Legal Compliance Officer Role at Penumbra
What are the responsibilities of a Legal Compliance Officer at Penumbra, Inc.?

As a Legal Compliance Officer at Penumbra, Inc., your main responsibilities will revolve around leading the operational aspects of the compliance program. This includes drafting and reviewing policies, performing regular risk assessments, overseeing audits, and providing compliance guidance to various departments. You'll also manage compliance training initiatives and work closely with outside counsel to ensure adherence to laws and regulations.

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What qualifications are required for the Legal Compliance Officer position at Penumbra, Inc.?

To qualify for the Legal Compliance Officer position at Penumbra, Inc., candidates should hold a bachelor's degree with a minimum of eight years of relevant experience in compliance, preferably in medical device, pharmaceutical, or biotech industries. Additionally, experience with global compliance requirements and Fair Market Value assessments is highly valued.

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What skills are essential for a Legal Compliance Officer at Penumbra, Inc.?

Essential skills for a Legal Compliance Officer at Penumbra, Inc. include strong oral and written communication abilities, attention to detail, and excellent organizational skills. You should also demonstrate proficiency in Microsoft Office applications and the capacity to manage multiple projects effectively while maintaining a compliance-first mindset.

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How does a Legal Compliance Officer at Penumbra, Inc. contribute to the company's culture?

A Legal Compliance Officer at Penumbra, Inc. contributes significantly to the company's culture by promoting a strong commitment to ethical standards and regulatory compliance. By building relationships across departments and providing training on compliance topics, you help foster an environment where employees prioritize ethics in their daily operations, reflecting Penumbra's values.

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What work environment can a Legal Compliance Officer expect at Penumbra, Inc.?

At Penumbra, Inc., a Legal Compliance Officer can expect a collaborative office environment. You'll engage regularly with various teams, participate in ongoing training, and enjoy the challenge of working on compliance matters crucial to the company's success. The role may involve minimal travel and offers the chance to make a tangible impact in the healthcare industry.

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Common Interview Questions for Legal Compliance Officer
Can you describe your experience with compliance in the medical device industry?

When discussing your experience with compliance in the medical device industry, highlight specific roles where you managed compliance tasks, mentioning relevant regulations you navigated. Be sure to relate how your actions improved compliance outcomes and ensured adherence to laws like the U.S. Physician Payments Sunshine Act.

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How do you approach risk assessments and audits?

In answering this, explain your structured approach to conducting risk assessments and audits. Share methodologies you use to identify potential compliance risks, your experience drafting audit reports, and how you recommend actionable solutions based on your findings.

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What strategies do you employ to foster a culture of compliance among employees?

Discuss strategies such as regular training programs, open lines of communication, and collaborative workshops to encourage compliance awareness. Share examples of how you effectively communicated compliance expectations and how you have engaged employees in these initiatives.

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How would you handle a compliance violation reported by an employee?

When addressing this question, emphasize the importance of a prompt and thorough investigation process. Outline steps to assess the violation, communicate with involved parties, and determine corrective actions, always ensuring confidentiality and a non-retaliatory approach.

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What is your experience managing external legal counsel?

In your response, refer to instances where you collaborated with outside legal counsel, explaining the types of issues you consulted on. Describe how you managed these relationships to ensure effective guidance on compliance initiatives or legal obligations.

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Can you give an example of a compliance program you developed or improved?

Share a specific example of a compliance program you spearheaded. Discuss initial challenges faced, methods you employed to enhance the program, and measurable outcomes that demonstrated improved compliance within the organization.

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How do you stay updated on changes to compliance regulations?

Emphasize your dedication to staying updated with changes in compliance regulations through network participation, relevant webinars, and continuous education. Mention any specific organizations or resources you rely on to keep your compliance knowledge current.

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Describe a time you had to provide compliance training to employees.

Highlight an experience where you successfully developed and delivered compliance training. Detail how you tailored the training content to the audience, engaged participants, and ensured that the key compliance messages resonated with them.

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How would you assess compliance risks in a new market Penumbra, Inc. is entering?

Discuss a systematic approach to assessing compliance risks, including conducting market research, engaging with local compliance experts, and identifying relevant laws and regulations. Explain how you would prepare risk mitigation strategies based on your findings.

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Why do you want to work at Penumbra, Inc. as a Legal Compliance Officer?

When answering this, express genuine enthusiasm for Penumbra's mission of saving lives through innovative healthcare solutions. Connect your professional values with the company's commitment to compliance and ethical standards, demonstrating that you are focused not only on the job but also on being part of an impactful organization.

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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 ...

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December 10, 2024

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