The ASP Regional Compliance Leader EMEA will adapt and execute the organization's Corporate Compliance Program in the EMEA region.
This individual will review and evaluate compliance issues / concerns within the region and work to manage and reduce a wide variety of compliance risks.
This will include implementing and improving compliance and risk management policies, programs and tools. This individual will also ensure that the employees are in compliance with the rules and regulations of all applicable regulatory agencies and our policies.
Duties and Responsibilities
Under limited supervision and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position will :
Industry Code Compliance : Ensure that the businesses and all associates in the region understand that our company expects that we follow country Codes of Ethics.
Compliance with the local code of ethics is an individual associate responsibility but the Regional Compliance Leader is responsible for communicating and supporting compliance.
Policies : Develop, update, and communicate policies to ensure continued compliance. Ensure that the global policies are tailored to meet the business needs and address the regional / country risks within the region.
Ensure that the appropriate compliance policies are being effectively communicated to associates, leaders, and functions in the region.
Partner with business partners to ensure that the compliance policies are operationalized though local standard work.
Training : Coordinating and providing compliance training on a wide variety of compliance and integrity topics, including train-the-trainers in the region.
Monitoring and Auditing : This will be a key strategic priority and the expectation is that the Regional Compliance Leader will identify risks, then implement a regional auditing and monitoring program in line with the company’s global compliance guidance and policies.
Third Party Diligence (Anti-Bribery / Anti-Corruption Compliance) : Assist in the training of third parties (i.e., distributors, agents, authorized service contractors) as appropriate.
Investigate and clear red flags related to new or current channel partners. Conduct auditing and monitoring of local channel partners.
Work closely with the ASP Compliance Operations Leader and provided the needed regional support.
Measuring Effectiveness : Track the elements of our compliance program using metrics to deliver accountability and to ensure the effective use of compliance tools.
Report compliance metrics to Fortive / ASP management.
Continuous Improvement : Monitor and assess significant changes in Healthcare and Medical Device related laws and regulations and compliance trends that apply to operations and activities.
Identify gaps in compliance awareness, policies, and tools and building countermeasures and sustainable and effective processes to close those gaps;
continuous improvement of compliance tools and other processes involving compliance policies, training and programs.
Program Management : Coordinate the roll out in the region of global compliance policies and tools. Maintain records of compliance training, investigations, and related activities.
Ensure internal transparency into the regional compliance practices, records and documents.
Risk Assessment : Manage and execute the annual risk assessment in partnership with the regional leadership teams. The goal is to identify risks, identify the root cause and then solving the root cause of the risks related to potential non-compliance and corruption.
Local Outside Counsel Management : Retain and managing outside counsel, auditors, or other experts as appropriate to assist in investigations, training, and other compliance-related projects.
Culture : Lead by example on the Fortive 9 set of core behaviors : Customer-obsessed, adaptable, delivers results, strategic, leads with FBS (Fortive Business System), innovates for impact, inspires, exhibits courage, and builds extraordinary teams.
Other assignments as needed.
5+ years compliance experience in healthcare compliance or healthcare law strongly preferred
English required. French / German / Russian / Spanish preferred
Six Sigma or Lead Certification preferred
An in-depth knowledge and understanding of applicable regulatory and compliance requirements for a medical device company, compliance risk management practices and methodologies, including risk assessment, monitoring / surveillance, and testing activities.
Knowledge and understanding of global and regional legal issues and laws facing global medical device companies including anti-bribery / anti-corruption (e.g. FCPA).
Strong project management skills, to include managing and prioritizing multiple concurrent projects and reporting progress and risks to colleagues and senior management.
Experience in conducting investigations and managing the entire investigative process, including the management and tracking of the investigation lifecycle and the close-out process.
Microsoft Office (Word, Excel, PowerPoint).
Domestic and international travel is required up to (30%).
Unquestioned integrity and excellent judgment.
Solid presentation, communications and influencing skills, demonstrated through all forms of communication.
A strong collaborative leadership style with ability to drive change and build followership across multiple business units, locations, organizational levels, and functions.
Strong time management and document management skills with attention to detail.
Cultural savvy : the ability to work effectively in a global environment and across numerous legal systems.
Process and results orientation. A history of building sustainable and innovative standard work and systems.
Keen problem solving skills, with a fondness for providing solutions or paths to resolution on complex matters.
Work closely with all EMEA emplyoees and managers and other internal Compliance functional roles Globally.
External interface with external consultants, unions and official bodies.
is a global family of more than 20 industry-leading industrial growth and technology companies, united by a shared purpose : to make the world stronger, safer, and more effective by providing essential technology for the people who accelerate progress.
Here, you get the excitement of a startup with the stability and predictability of an organization strongly grounded in its roots and with a proven track record of growth.
There’s no limit to what you can learn, or the impact you can make : for you, for us, for growth. Come join our team at Advanced Sterilization Products (ASP) and be part of a global leader in infection prevention solutions for the healthcare industry.
With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities.
Add your talent to our extraordinary team and help us in our mission to make healthcare safer for everyone. ASP is based in Irvine, California with core sites in Everett, Washington and Schaffhausen, Switzerland plus many more offices around the world.