Compliance Manager, BIOTRONIK NEURO

BIOTRONIK; Lake Oswego (OR); Remote; USD 154,000 - 240,000; Full time

Job summary

BIOTRONIK is seeking a Compliance Manager for the BIOTRONIK NEURO division to oversee compliance programs and processes. This critical role involves drafting compliance policies, conducting risk assessments, and ensuring adherence to legal standards. The successful candidate will have 5+ years’ experience in compliance, particularly within the medical technology sector, and will demonstrate strong analytical skills and integrity.

Qualifications

• 5+ years’ experience in a compliance role, preferably in medical technology.
• Experience in compliance investigations and ethics, with a strong commitment to integrity.

Responsibilities

• Manage and draft compliance policies for BIOTRONIK NEURO.
• Conduct annual Risk Assessments and develop compliance training programs.

Skills

Compliance Regulations

Data Analysis

Strong Integrity

Analytical Skills

Education

Bachelor’s Degree

Tools

MS Excel

Job description

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As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

The Compliance Manager of BIOTRONIK NEURO will build and drive key program elements and activities associated with the management and continuous improvement of BIOTRONIK NEURO’s Compliance program. The Compliance Manager will operate in a multi-disciplinary and interdepartmental capacity, will enact controls, develop appropriate compliance processes and guidelines, and assure adherence, thereof and elevate employees’ understanding of compliance. The Compliance Manager is a recognized subject matter expert, relied upon throughout the company, in various elements of BIOTRONIK NEURO’s Compliance program. Reporting of the Compliance Manager position will be directly to the President.

Your Responsibilities

• Leveraging policies and procedures developed by BIOTRONIK, Inc.’s Compliance Program, manage and draft relevant Compliance policies for BIOTRONIK NEURO.
• With support from the Legal Department, develop, conduct, and lead annual Risk Assessment efforts including anticipating and identifying areas of risk for the company, proactively identifying steps for remediation, and collaborating on metrics.
• Create and execute, with support from the Legal Department, the Annual Compliance Monitoring plan leveraging results from the Risk Assessment.
• Develop, lead and execute compliance training programs leveraging resources and materials developed by BIOTRONIK, Inc.’s Compliance Program.
• With support from HR and Legal, participate and lead compliance investigations and conflict of interest reviews and remedial action efforts.
• Respond to day-to-day Ethics & Compliance questions based on established policies and procedures.
• Leveraging efforts and program materials from BIOTRONIK, Inc. design the compliance parameters around use of HCP consultants. Update as needed.
• Lead interdepartmental initiatives and task forces related to compliance.
• Create effective communications on compliance related topics to be sent periodically to applicable business functions.
  
  

Your Profile

• 5+ years’ experience in a compliance role; preference for a medical technology or pharmaceutical company, and demonstrated knowledge of applicable compliance regulations, standards, laws, and trends.
• Direct experience with contracting with healthcare professionals.
• Bachelor’s Degree is required. Relevant fields are preferred but will consider all majors.
• At least 3 years of experience within a medical device organization.
• Core 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
• Strong integrity/ethics and commitment to excellence.
• Ability to navigate in a cross-functional environment
• Strong data analysis interest and experience
• Ability to tackle new projects and lead efforts and staff.
• Experience conducting compliance 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.
  
  

Preferred Education and Experience:

• Experience working with other relevant life science or a 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).
  
  

Travel Requirements:

Limited travel is required, usually less than 15% per year.

Supervisory Responsibilities:

Lead functional work teams as needed. This position will not start with any direct reports.

Work Environment:

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

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This is a largely sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. 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.

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.

Location:

This is a remote position.

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

Location: Remote out of Lake Oswego, OR | Working hours: Full-time | Type of contract: Undefined

Apply now under: www.biotronik.com/careers

Job ID: 61158 | BIOTRONIK NRO 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Medical Equipment Manufacturing

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