Senior Corporate Compliance Specialist - Medical Device

FUJIFILM Corporation; Denver (CO); Remote; USD 69,000 - 110,000; Full time

Job summary

A leading company in healthcare seeks a Senior Corporate Compliance Specialist to enhance their compliance program. The role involves developing policies, conducting risk assessments, and ensuring ethical standards. Ideal candidates will have a Bachelor's degree and relevant experience in the medical device or pharmaceutical industry.

Qualifications

• 2 to 3 years of corporate compliance experience in medical device/pharmaceutical industry.
• Working knowledge of healthcare related laws and regulations.

Responsibilities

• Develop and implement compliance program elements.
• Conduct compliance risk assessments and audits.
• Support compliance training for employees.

Skills

Communication

Analytical Abilities

Project Management

Education

Bachelor’s Degree

Tools

MS Office

Job description

The accomplished Senior Corporate Compliance Specialist will support FUJIFILM’s Corporate Compliance Program’s operations to ensure high ethical standards are observed and the compliance program is effective and efficient. The successful candidate will operate independently and with limited management oversight. The position will report to the Compliance Officer.

Company Overview

FUJIFILM Healthcare Americas Corporation is a comprehensive healthcare company that has an extensive range of technology and expertise in the detection, diagnosis, and treatment of diseases. Fujifilm’s innovative portfolio includes solutions spanning diagnostic imaging, enterprise imaging, endoscopic imaging, surgical imaging, and in-vitro diagnostics. The company is headquartered in Lexington, Massachusetts. For more information, please visit healthcaresolutions-us.fujifilm.com .

FUJIFILM Holdings Corporation, headquartered in Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver innovative products and services across the globe through the four key business segments of healthcare, electronics, business innovation, and imaging with over 70,000 employees. Guided and united by our Group Purpose of “giving our world more smiles,” we address social challenges and create a positive impact on society through our products, services, and business operations. Under its medium-term management plan, VISION2030, which ends in FY2030, we aspire to continue our evolution into a company that creates value and smiles for various stakeholders as a collection of global leading businesses and achieve a global revenue of 4 trillion yen (29 billion USD at an exchange rate of 140 JPY / USD). For more information, please visit : www.fujifilmholdings.com .

For further details about our commitment to sustainability and Fujifilm’s Sustainable Value Plan 2030,click here () .

Job Description

Duties and responsibilities

Develop and implement elements that support FUJIFILM’s Corporate Compliance Program in line with OIG’s guidance of an effective compliance program and industry best practices.

Promote a culture of compliance and sound ethical behavior.

Conduct compliance policy and procedure assessment, and support development and implementation of new or updated polices, procedures, or systems to address new risk areas or to improve operations and / or internal controls.

Support the compliance training program to educate employees, including new hires, on legal and ethical standards and to ensure a comprehensive understanding. Assist in identifying compliance training needs, develop and deliver training to employees to ensure awareness, understanding, and compliance with policies / procedures and regulations.

Build partnership with business teams and provide guidance on questions related to compliance program, process, and requirements. Understand and support business strategy and collaborate with business teams and other business groups as necessary to design and implement appropriate controls to manage potential compliance risks.

Conduct compliance risk assessment and analysis, identify potential risks and improvement opportunities, develop and implement action plans, and follow up on status and effectiveness.

Develop and execute auditing and monitoring plans, conduct root cause analysis, collaborate with business and other stakeholders to develop preventive and corrective action plans, track status of action plans, and prepare related reports.

Manage transparency data collection, validation, and reporting process to ensure compliance with the applicable transparency reporting requirements (e.g., the Physician Payments Sunshine Act).

Manage Third Party program including the due diligence process, annual certifications, training, and other applicable programs.

Support compliance operations and initiatives from the FUJIFILM Holdings America Corporation as required including incident reporting, auditing / monitoring, training, and investigations.

Manage user access and updates required for compliance systems.

Assist with due diligence review and integration related to Mergers & Acquisitions activities.

Keep abreast of new legislation and enforcement matters relevant to the medical device industry as well as industry and compliance best practices.

Perform other Compliance Department projects and initiatives, as assigned.

Required qualifications

Bachelor’s Degree.

2 to 3 years of corporate compliance experience in the medical device and / or pharmaceutical industry and working knowledge of healthcare related laws and regulations (including Anti-Kickback Statute, Foreign Corrupt Practices Act (FCPA), False Claims Statute, and OIG’s guidance of an effective compliance program) as well as applicable industry codes (e.g., AdvaMed Code on Interactions with Healthcare Professionals).

Self-starter and ability to work both independently and collaboratively as needed.

Strong written and verbal communication skills.

Positive attitude and great interpersonal skills to work with multifunctional business teams and stakeholders.

Strong analytical abilities and proficiency with MS Office (e.g., PowerPoint, Excel, and Word).

Preferred qualifications

Excellent project management skills.

Healthcare Compliance Certification.

Experience with data analytic tools.

Experience with monitoring and auditing of compliance related activities.

Physical requirements

The position requires the ability to perform the following physical demands and / or have the listed

capabilities :

The ability to sit up to 75-100% of applicable work time.

The ability to use your hands and fingers to feel and manipulate items, including keyboardsup to 100% of applicable work time.

Ability to stand, sit, talk, and hear for 75% of applicable work time.

Travel

• Occasional (up to 20%) travel may be required based on business need.

Salary Range

• 69,525 - $110,000

In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

Applicants to positions where vendor credentialing or other similar requirements exist to enter facilities will be required to comply with the credentialing requirements of the facilities, including complying with vaccine requirements.

For all positions, the Company encourages vaccination against COVID-19 and requires that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail] or [phone]).

Job Locations US-Remote

Requisition ID 2025-33401

Category Regulatory / Compliance

Company (Portal Searching) FUJIFILM Healthcare America Corporation

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