Senior Director, Corporate Counsel & Compliance - Edwards Lifesciences
Naperville, IL
About the Job
_Edwards Lifesciences is growing and our_ _Senior Director, Corporate Counsel and Compliance_ _position is a unique career opportunity that could be your next step towards an exciting future. This role will sit within the Endotronix team, who develop implantable heart monitoring technology. Endotronix was acquired by Edwards in July 2024, and will support our future work with heart failure management solutions to address large unmet structural heart patient needs and support sustainable long-term growth._
_For more details on the acquisition, please visit:_ _https://www.edwards.com/newsroom/news/2024-07-24-edwards-lifesciences-expands-structural-heart-port_
The Senior Director, Corporate Counsel and Compliance reports to the Senior Vice President, Associate General Counsel with dotted line reporting to the Chief Compliance Officer and Corporate Vice President, Implantable Heart Failure Management. The Sr Director will serve as the general counsel and compliance lead for the Implantable Heart Failure Management (IHFM) business unit and will partner with leadership on legal and compliance strategies in alignment with business priorities and strategic goals.
Work Schedule: Given the collaborative and complex nature of this work, this role is in person full time in Naperville, IL with flexibility to occasionally work from home as needed.
How you will make an impact:
+ Act as the legal subject matter expert for IHFM client groups and serve in an advisory role for IHFM executive leadership. Provide expert legal advice and guidance on a wide range of digital health matters, including mobile health applications, medical device regulations, and data privacy and security. Provide counsel and guidance to project teams in connection with IHFM-level strategies, projects, initiatives, and programs.
+ Oversee all IHFM legal department activities such as: legal research, complex contract drafting and negotiation; tracking, review and interpretation of legislation; and litigation management
+ Support senior and executive leadership in establishing an IHFM business unit of Edwards. Identify unmet law and compliance needs and future issues and proactively propose strategies to optimize outcomes and results for IHFM and Edwards.
+ Drive IHFM efforts to implement the global compliance program and all of its elements, including policies, processes and systems while adapting the program to variations for the IHFM business. This includes assessing and monitoring compliance with applicable laws, regulations, and industry standards related to digital health operations.
+ Influence outcomes and resolutions with executive leadership; oversee IHFM compliance training programs and provide direction in development and implementation of new compliance initiatives. Serve in an advisory role to IHFM executive leadership on compliance issues.
+ Manage supporting and subordinate legal and compliance team members and direct activities with overall responsibility for the successful operation of assigned areas through lower management levels where the scope and complexity of responsibilities require the integration of multiple disciplines and departments; provide feedback and guidance to staff on assignments and assigned areas and may manage other attorneys and professional
+ Ensure broader Edwards legal and compliance function is informed of IHFM-specific activities.
+ Serve as legal advisor to support Edwards interests before state and city government agencies as we expand our facilities in Naperville, IL.
What you'll need (Required):
+ Juris Doctor from ABA-accredited law school with minimum 11 years of legal experience at a reputable law firm or in-house legal department, or other comparable experience.
+ Licensed by at least one US state bar association
+ Experience with early-stage commercial launch in medical device or life science company
+ In-depth knowledge of healthcare regulations (e.g., HIPAA, HITECH Act, FDA regulations) and technology-related laws (e.g., data protection, cybersecurity).
+ Demonstrated ability to review and advise on promotional materials, sales training materials, and corporate communications (including social media)
+ Demonstrated ability to review and advise on interactions with patients, caregivers, physicians and other healthcare providers, payers, regulatory agencies, and government reimbursement programs
+ Excellent facilitation and presentation skills
+ Excellent skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
+ Strong communication and interpersonal skills, including the ability to convey complex legal and transactional concepts/issues clearly and succinctly to legal and business decision makers.
+ Expert understanding of procedures with extensive and detailed knowledge of company allows for innovative concepts and promoting new ideas
+ Expert knowledge documentation and communication and understanding of Edwards policies, procedures, and guidelines relevant to compliance
+ Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
+ Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of corporate responsibility to the business
+ Expert understanding of effective compliance program standards
+ Strict attention to detail
+ Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
+ Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment
+ Ability to interact internally and externally with executive level management, requiring negotiation of extremely critical matters; influences policymaking
+ Ability to dedicate to quality client service and pro-active and responsive to client needs
+ Ability to develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
+ Ability to develop relationships and leverage them to influence change.
+ Ability to support and solicit input from team members at all levels within the organization.
+ Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
+ Proven expertise in MS Office Suite (e.g., Word, Outlook, Excel, PowerPoint) required
+ Proven successful project management skills
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For Illinois (IL), the base pay range for this position is $204,000 to $289,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
_For more details on the acquisition, please visit:_ _https://www.edwards.com/newsroom/news/2024-07-24-edwards-lifesciences-expands-structural-heart-port_
The Senior Director, Corporate Counsel and Compliance reports to the Senior Vice President, Associate General Counsel with dotted line reporting to the Chief Compliance Officer and Corporate Vice President, Implantable Heart Failure Management. The Sr Director will serve as the general counsel and compliance lead for the Implantable Heart Failure Management (IHFM) business unit and will partner with leadership on legal and compliance strategies in alignment with business priorities and strategic goals.
Work Schedule: Given the collaborative and complex nature of this work, this role is in person full time in Naperville, IL with flexibility to occasionally work from home as needed.
How you will make an impact:
+ Act as the legal subject matter expert for IHFM client groups and serve in an advisory role for IHFM executive leadership. Provide expert legal advice and guidance on a wide range of digital health matters, including mobile health applications, medical device regulations, and data privacy and security. Provide counsel and guidance to project teams in connection with IHFM-level strategies, projects, initiatives, and programs.
+ Oversee all IHFM legal department activities such as: legal research, complex contract drafting and negotiation; tracking, review and interpretation of legislation; and litigation management
+ Support senior and executive leadership in establishing an IHFM business unit of Edwards. Identify unmet law and compliance needs and future issues and proactively propose strategies to optimize outcomes and results for IHFM and Edwards.
+ Drive IHFM efforts to implement the global compliance program and all of its elements, including policies, processes and systems while adapting the program to variations for the IHFM business. This includes assessing and monitoring compliance with applicable laws, regulations, and industry standards related to digital health operations.
+ Influence outcomes and resolutions with executive leadership; oversee IHFM compliance training programs and provide direction in development and implementation of new compliance initiatives. Serve in an advisory role to IHFM executive leadership on compliance issues.
+ Manage supporting and subordinate legal and compliance team members and direct activities with overall responsibility for the successful operation of assigned areas through lower management levels where the scope and complexity of responsibilities require the integration of multiple disciplines and departments; provide feedback and guidance to staff on assignments and assigned areas and may manage other attorneys and professional
+ Ensure broader Edwards legal and compliance function is informed of IHFM-specific activities.
+ Serve as legal advisor to support Edwards interests before state and city government agencies as we expand our facilities in Naperville, IL.
What you'll need (Required):
+ Juris Doctor from ABA-accredited law school with minimum 11 years of legal experience at a reputable law firm or in-house legal department, or other comparable experience.
+ Licensed by at least one US state bar association
+ Experience with early-stage commercial launch in medical device or life science company
+ In-depth knowledge of healthcare regulations (e.g., HIPAA, HITECH Act, FDA regulations) and technology-related laws (e.g., data protection, cybersecurity).
+ Demonstrated ability to review and advise on promotional materials, sales training materials, and corporate communications (including social media)
+ Demonstrated ability to review and advise on interactions with patients, caregivers, physicians and other healthcare providers, payers, regulatory agencies, and government reimbursement programs
+ Excellent facilitation and presentation skills
+ Excellent skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
+ Strong communication and interpersonal skills, including the ability to convey complex legal and transactional concepts/issues clearly and succinctly to legal and business decision makers.
+ Expert understanding of procedures with extensive and detailed knowledge of company allows for innovative concepts and promoting new ideas
+ Expert knowledge documentation and communication and understanding of Edwards policies, procedures, and guidelines relevant to compliance
+ Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
+ Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of corporate responsibility to the business
+ Expert understanding of effective compliance program standards
+ Strict attention to detail
+ Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
+ Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment
+ Ability to interact internally and externally with executive level management, requiring negotiation of extremely critical matters; influences policymaking
+ Ability to dedicate to quality client service and pro-active and responsive to client needs
+ Ability to develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
+ Ability to develop relationships and leverage them to influence change.
+ Ability to support and solicit input from team members at all levels within the organization.
+ Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
+ Proven expertise in MS Office Suite (e.g., Word, Outlook, Excel, PowerPoint) required
+ Proven successful project management skills
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For Illinois (IL), the base pay range for this position is $204,000 to $289,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Source : Edwards Lifesciences