Advanced Sterilization Products (ASP) is a worldwide healthcare supplier with infection control solutions. With specialized surgical sterilization and disinfection products, processes, and workflows, ASP is committed to protecting the lives of patients, relatives, healthcare staff, providers, and societies. Nothing is more critical in healthcare than protecting patients. The protection of the treatment environment, including medical instruments and equipment that come into contact with vulnerable patients, is therefore critical. With main locations in Everett, Washington, Schaffhausen, Switzerland, and Irvine, California, plus several other offices around the world. It provides various incentives to the team such as holidays, 401K plans, life insurance, and assessment program.
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.
At ASP, we believe in you. We believe in your potential – your ability to learn, grow, and contribute in meaningful ways. We believe in the power of great people working together to innovate and solve problems no one could solve alone. We build enduring partnerships with our customers and take on their challenges and opportunities as our own. If this excites you, we want to hear from you!
Your Impact:
The Americas Compliance Leader will report to the ASP Chief Compliance Officer. We are looking for expert level compliance leader to contribute to the development of functional strategy and oversee the organization’s Corporate Compliance Program in the Americas region. The right leader will anticipate business and regulatory issues, strategically incorporate lean/continuous improvement into our program, lead projects with notable risk and complexity; and develop the strategy for project execution. Day to day you will review and evaluate compliance issues/concerns within the region, including implementing and improving compliance policies, training, auditing, monitoring, programs and tools in the region. You will work closely with your client groups and support them to ensure that they are able to perform their jobs in compliance with our policies, expectations, rules and regulations.
Key Responsibilities:
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 : Creating and delivering compliance training on a wide variety of compliance and integrity topics, including “train-the-trainers” in the region.
Internal Investigations: Promote the Speak Up! whistleblower program; perform and lead internal investigations and develop action plans and countermeasures.
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 Compliance Operations Leader and provided the needed regional support.
Healthcare Compliance : Manage transparency reporting, advertising and promotional reviews, grants/donations/sponsorships reviews, training and education programs, healthcare professional services agreements, and pricing reviews that require compliance review in the Americas region.
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.
Measuring Effectiveness : Track the elements of our compliance program using metrics to deliver accountability and to ensure the effective use of compliance tools. Report on compliance metrics.
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, pre reviews, and related activities. Ensure internal transparency into the regional compliance practices, records and documents.
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 .
Here’s what we’ll need from you:
University degree required. J.D. or Six Sigma Certificate strongly preferred.
Language: English required, Spanish a must.
4+ years compliance experience in healthcare strongly preferred.
Strong project management skills, to include managing and prioritizing multiple concurrent projects and reporting progress and risks to colleagues and senior management.
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).
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 15%.
Here are a few examples of the traits we value:
Unquestioned integrity and excellent judgment.
Excellent organizational skills, exceptional subject matter expertise, a high degree of adaptability and the ability to anticipate and respond to changing priorities.
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.
Executive presence with ability to inspire confidence and gain & hold the trust of senior management.
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.
Fortive 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.
We Are an Equal Opportunity Employer
Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should ask to speak with a Human Resources representative to request an accommodation.
National: The salary range for this position is $118,800- $220,600
This position is also eligible for bonus as part of the total compensation package.
Base pay offered may vary depending on various factors, including, but not limited to: job-related knowledge; skills; experience; and other eligibility factors such as geographic location. The Total Rewards package includes competitive base pay and an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and several programs that provide for both paid and unpaid time away from work.
