Compliance Manager

Compliance Manager

BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.

Join one of the most dynamic compliance teams in healthcare today! Our Ethics and Compliance Department is a cohesive, forward-thinking team dedicated to upholding BIOTRONIK’s core values of ethical business practices.

As the Compliance Manager, you will lead key initiatives to manage and continuously improve BIOTRONIK Inc.’s Ethics and Compliance program. In this role, you’ll collaborate across departments, driving company-wide improvements, enhancing internal controls, and elevating employees' understanding of compliance.

As a recognized subject matter expert, you will play a pivotal role in influencing strategic decisions and shaping company policy. Your expertise will be integral to ensuring BIOTRONIK's commitment to the highest standards of ethical conduct, giving you a unique opportunity to make a significant impact on the organization.

Your Responsibilities

• Develop and conduct compliance training programs both live and virtual, as well as online courses.
• Enhance existing compliance policies and develop communication and training tied to such changes.
• Conduct field force monitoring and speaker program monitoring.
• Assist VP, Compliance & Risk Management and other Compliance Managers to develop existing compliance staff.
• Conduct back-office monitoring and auditing based on results of the Risk Assessment and identification of risk areas.
• Be a primary support to the operation and execution of Corporate Integrity Agreement requirements and obligations.
• Conduct and manage compliance investigations and needed remedial measures with support of other Compliance Managers.
• Based upon the outcome of audit and monitoring findings and investigations, work with the other Compliance Managers to review and/or revise existing compliance policies, SOPs and Work Instructions.
• Be the compliance lead for HCP consultant engagement questions and conduit to the Marketing Department arm that drafts and executes the agreements.
• Help prepare for Board Meetings and Compliance Committee Meetings.
• Assist in all transparency and compliance filings.
• Drive the development, implementation, and continuous improvement of an effective Ethics & Compliance Program.
• Lead interdepartmental initiatives and task forces.
• Perform other duties as assigned.

Your Profile

• Bachelor’s Degree is required. Relevant fields are preferred, but will consider all majors.
• At least 5 years of experience in a Compliance/Ethics or Legal function or direct experience working in a function within a healthcare company that dealt with physician engagements.
• Direct experience in a Medical Device organization.
• Ability to navigate in a cross-functional environment
• Strong data analysis interest and experience
• Ability to tackle new projects and lead efforts and staff
• Knowledge and understanding of applicable regulations, recent enforcement actions and trends (e.g. Corporate Integrity Agreements in the life science industry), and ethics & compliance best practices including:
  • AdvaMed Code of Ethics,
  • Anti-Kickback Statute
  • False Claims Act
  • Physician Payments Sunshine Act
• Some experience conducting investigations, determining root cause, and driving corrective actions.
• Strong analytical and decision-making skills. Ability to absorb and analyze large amounts of information and make decisions by weighing evidence, alternatives, risks, etc. Data analysis and audit experience is a plus.
• Ability to apply project management and change management techniques to internal projects.
• Excellent communication skills, including the ability to communicate with high-level management, to influence others without authority when necessary, and to conduct contentious and critical investigative interviews.
• Positive attitude and willingness to work as part of a team and mentor other team members.
• Ability to work independently as needed.
• Capacity to serve as a team leader and meet ambitious project milestones and objectives.
• Strong organizational skills and attention to detail.
• Proficient PC application skills, including knowledge of MS Excel, email systems, etc. Experience with enterprise systems (e.g. SAP, Oracle, Concur, Salesforce) or business intelligence/data analysis tools is a plus.
• Strong integrity/ethics and commitment to excellence.

Preferred Education and Experience

• Experience working in the medical device, life science, or healthcare industry.
• Significant experience navigating a cross-functional environment or an advanced degree (e.g. Master’s in health related discipline degree) and/or certification (e.g. CCEP).

Supervisory Responsibilities

Lead functional work teams as needed. This position will not start with any direct reports but that could change within the first 6 month.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

Physical Demands

• This is a largely sedentary role. While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to talk and hear. All reasonable accommodations will be made.

Position Type/Expected Hours of Work

• This is a full-time position. Standard days of work are Monday through Friday. Hours of work may vary depending on time zone supported. Occasional evening and weekend work may be required as job duties demand.

Travel

• Travel is required, approximately fifteen percent (15%) per year.

Location

• This position will be ideally based in California, Oregon or Texas and will be remote.

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Lake Oswego, Oregon | Working hours: Full-time | Type of contract: Undefined

Job ID: 59937 | BIOTRONIK Inc. | USA

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law. Please note that applications sent by post will only be returned if a sufficiently stamped self-addressed envelope is included.