AtriCure, Inc.
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure\'s Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure\'s AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure\'s Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure\'s cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure. We foster a culture of inclusion by embracing diverse experiences and individuals where everyone\'s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
Position Summary We are seeking a strategic and experienced
Compliance Director
to oversee and manage the compliance program across the
Americas region
(North, Central, and South America). This individual will ensure adherence to applicable
healthcare, anti-corruption, regulatory, and data privacy laws . The role requires strong leadership, risk management acumen, and the ability to partner cross-functionally with commercial, legal, regulatory, and operational teams. This is an individual contributor role with the opportunity for growth.
Responsibilities
Develop, implement, and oversee
the regional compliance strategy in alignment with global corporate policies and regulatory requirements
Serve as a
subject matter expert
on healthcare compliance (including Anti-Kickback Statute, False Claims Act, FCPA, AdvaMed Code, and local equivalents in LATAM and Canada)
Lead the
risk assessment and mitigation process for the Americas , identifying and addressing emerging compliance risks in the Americas region.
Involvement with the
third-party due diligence
process, including distributors, consultants, and vendors.
Partner with legal, and HR teams to
investigate and remediate compliance incidents .
Support
monitoring and auditing
programs and remediate identified issues.
Collaborate with commercial leaders to ensure compliant business practices, particularly around
interactions with healthcare professionals (HCPs) and referral sources .
Review HCP engagement needs assessments, participate in research grants and educational grants review committees
Represent the region in global compliance meetings and projects , acting as the voice of the Americas in shaping company-wide compliance initiatives.
Keep abreast of
regulatory changes
and enforcement trends affecting the medical device industry.
Assisting in drafting, reviewing, revising, and implementing compliance
policies and procedures
globally
Providing recommendations for and supporting the execution of the
training and communication plan
Participate in conducting
risk assessments
to detect process deficiencies, and revise and recommend changes to the Work Plan to address the identified deficiencies
Conduct
annual risk assessments
and recommend changes to the Annual Work Plan accordingly
Other duties as assigned by the Chief Compliance Officer
Additional Responsibilities
Regular and predictable worksite attendance or remote work as agreed to with the Chief Compliance Officer
Ability to work under fast-paced conditions
Ability to make decisions and use good judgement
Ability to prioritize various duties and multitask as required
Ability to successfully work with others
Additional duties as assigned
Qualifications
Bachelor of Arts or Bachelor of Science
Minimum of 10 years of healthcare industry experience, with at least five years\' experience in pharmaceutical or medical device compliance management
Absolute commitment to integrity and professional ethics
Expertise in anti-kickback, anti-bribery, anti-corruption laws, and privacy laws applicable to the Americas as well as FDA on-label promotional requirements.
Strong knowledge of the AdvaMed Code
Strong organizational, interpersonal, analytical and communication skills
Proven track record of both strategic and tactical capabilities, demonstrating the ability to:
Innovate and execute in a complex business environment
Foster relationships and influence business decisions and business partners, both throughout the company and external parties
Combine regional orientation with global goals and objectives
Manage complex, cross functional or global projects to conclusion
Committed team player while taking initiative to get results with minimal supervision
Ability to travel regionally (up to 25%)
Preferred Qualifications
Prior experience as Compliance Officer for a business unit or operational region of a medical device, biotech or pharmaceutical company
JD, MBA, or other professional degree preferred
Other Requirements
Ability to regularly walk, sit, or stand as required
Ability to occasionally bend and push/pull
Ability to regularly lift up to 25 pounds, occasionally lift up to 25 pounds
Ability to pass pre-employment drug screen and background check
Up to 25% travel may be required
#LI-KN1
Benefits AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits. AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).
#J-18808-Ljbffr
Position Summary We are seeking a strategic and experienced
Compliance Director
to oversee and manage the compliance program across the
Americas region
(North, Central, and South America). This individual will ensure adherence to applicable
healthcare, anti-corruption, regulatory, and data privacy laws . The role requires strong leadership, risk management acumen, and the ability to partner cross-functionally with commercial, legal, regulatory, and operational teams. This is an individual contributor role with the opportunity for growth.
Responsibilities
Develop, implement, and oversee
the regional compliance strategy in alignment with global corporate policies and regulatory requirements
Serve as a
subject matter expert
on healthcare compliance (including Anti-Kickback Statute, False Claims Act, FCPA, AdvaMed Code, and local equivalents in LATAM and Canada)
Lead the
risk assessment and mitigation process for the Americas , identifying and addressing emerging compliance risks in the Americas region.
Involvement with the
third-party due diligence
process, including distributors, consultants, and vendors.
Partner with legal, and HR teams to
investigate and remediate compliance incidents .
Support
monitoring and auditing
programs and remediate identified issues.
Collaborate with commercial leaders to ensure compliant business practices, particularly around
interactions with healthcare professionals (HCPs) and referral sources .
Review HCP engagement needs assessments, participate in research grants and educational grants review committees
Represent the region in global compliance meetings and projects , acting as the voice of the Americas in shaping company-wide compliance initiatives.
Keep abreast of
regulatory changes
and enforcement trends affecting the medical device industry.
Assisting in drafting, reviewing, revising, and implementing compliance
policies and procedures
globally
Providing recommendations for and supporting the execution of the
training and communication plan
Participate in conducting
risk assessments
to detect process deficiencies, and revise and recommend changes to the Work Plan to address the identified deficiencies
Conduct
annual risk assessments
and recommend changes to the Annual Work Plan accordingly
Other duties as assigned by the Chief Compliance Officer
Additional Responsibilities
Regular and predictable worksite attendance or remote work as agreed to with the Chief Compliance Officer
Ability to work under fast-paced conditions
Ability to make decisions and use good judgement
Ability to prioritize various duties and multitask as required
Ability to successfully work with others
Additional duties as assigned
Qualifications
Bachelor of Arts or Bachelor of Science
Minimum of 10 years of healthcare industry experience, with at least five years\' experience in pharmaceutical or medical device compliance management
Absolute commitment to integrity and professional ethics
Expertise in anti-kickback, anti-bribery, anti-corruption laws, and privacy laws applicable to the Americas as well as FDA on-label promotional requirements.
Strong knowledge of the AdvaMed Code
Strong organizational, interpersonal, analytical and communication skills
Proven track record of both strategic and tactical capabilities, demonstrating the ability to:
Innovate and execute in a complex business environment
Foster relationships and influence business decisions and business partners, both throughout the company and external parties
Combine regional orientation with global goals and objectives
Manage complex, cross functional or global projects to conclusion
Committed team player while taking initiative to get results with minimal supervision
Ability to travel regionally (up to 25%)
Preferred Qualifications
Prior experience as Compliance Officer for a business unit or operational region of a medical device, biotech or pharmaceutical company
JD, MBA, or other professional degree preferred
Other Requirements
Ability to regularly walk, sit, or stand as required
Ability to occasionally bend and push/pull
Ability to regularly lift up to 25 pounds, occasionally lift up to 25 pounds
Ability to pass pre-employment drug screen and background check
Up to 25% travel may be required
#LI-KN1
Benefits AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits. AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).
#J-18808-Ljbffr