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Senior Manager, Global Compliance

Pentax Medical

Watson Lake

On-site

CAD 164,000 - 207,000

Full time

Today
Be an early applicant

Job summary

A leading medical device company is looking for a Director of Global Compliance to oversee compliance initiatives and collaborate with multiple stakeholders. The ideal candidate will have extensive experience in compliance within the medical device industry, a strong knowledge of applicable regulations, and demonstrated leadership skills. This role offers the opportunity to shape compliance strategy and ensure adherence to legal standards.

Benefits

Comprehensive benefits program
Generous Paid Time Off

Qualifications

  • 10+ years progressive experience in compliance or related field.
  • Knowledge of key laws (e.g., AKS, Sunshine Act) affecting the medical device industry.

Responsibilities

  • Manage and enhance corporate compliance program across Americas.
  • Develop and assess compliance policies and procedures.
  • Ensure training plans meet regulatory standards.
  • Oversee global transparency reporting program.
  • Collaborate on compliance investigations and enforcement activities.

Skills

Strong knowledge of medical device regulations
Problem-solving skills
Ability to work in a fast-paced environment
Team-oriented

Education

Bachelor's degree
Advanced degree or law degree preferred
Job description

Position:Senior Manager, Global Compliance

Location: Atlanta, GA, 30303

Job Id:20250902SMGC

# of Openings:1

About PENTAX Medical

Our mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community.

Position Opening: Director, Global Compliance

Why JOIN Us?

We are an established medical device leader that is preparing for high growth. This means that PENTAX is looking to invest in its team and provide a collaborative and encouraging work environment.

PENTAX Medical is proud of its comprehensive benefits program and generous Paid Time Off and Holiday policy.

Role Overview

The Director, Global Compliance will be a member of the Global Compliance team, providing day-to-day management of compliance program initiatives, primarily for the Americas. This role will provide support and guidance to the Americas Sales and Marketing teams serving as Compliance Business Partner. This role will have direct or indirect responsibility for managing specific compliance programs and projects, including Pentax Medical’s Spend Transparency; Grants and Donations; engagement of healthcare professionals; new and existing compliance policies and SOPs; compliance communication and awareness materials; employee training; global risk management and compliance investigations as directed by the Chief Compliance Officer. Will have direct responsibility for direct report(s).

Responsibilities, Director, Global Compliance
  • Partner with multiple stakeholders throughout the PENTAX Medical organization (legal, HR, operations, internal audit, QA/RA, sales and marketing) with primary focus on the Americas to manage and enhance an effective corporate compliance program and function and ensure that appropriate compliance policies, procedures, and internal controls are in place
  • Develop, maintain and regularly assess key policies and procedures to mitigate identified risks and meet government and healthcare compliance requirements
  • Ensure curriculum and training plans align with Business needs and regulatory/legal requirements and that training completion rate remains at 100%
  • Oversee the global transparency reporting program, ensuring compliance with all applicable spend disclosure and reporting laws and regulations
  • Understand relevant laws and regulations in key global markets to ensure that PENTAX Medical policies and business practices align with such laws and regulations
  • Oversee the maintenance of the anti-bribery due diligence screening process for third parties who conduct business with or on behalf of PENTAX Medical
  • Assist with monitoring and enforcement of compliance efforts, including compliance monitoring activities; risk assessments and reviews of compliance risk areas to determine risk exposure; ongoing collaboration with key stakeholders to identify any issues of non-compliance; and summarize and report same to the Chief Compliance Officer
  • Conduct and manage compliance investigations regarding allegations of law or company policy or ethical standards and prepare written reports on the findings of such investigations, as directed by the Chief Compliance Officer. Assist with the determination and implementation of corrective actions
  • Collaborate with the Chief Compliance Officer and global team to continue to enhance the culture of ethics and compliance at PENTAX Medical
  • Serve as a resource and subject matter expert for all healthcare compliance related activities
  • Lead on other projects as assigned from time to time
Requirements, Director, Global Compliance
  • Bachelor's degree; Advanced degree or law degree preferred, but not required.
  • 10+ years progressive experience
  • Strong knowledge of key laws and regulations impacting the medical device or life science industry (e.g., AKS, Sunshine Act)
  • Team oriented, with ability to problem solve and work in a fast paced, ever changing environment

It is the ongoing policy and practice of PENTAX Medical to provide equal opportunity in employment to all employees and applicants. No person shall be discriminated against in any condition of employment because of age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law.

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