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Director, Corporate Compliance EMEA

Posted 26 Mar 2024
Work experience
7 to 10 years
Full-time / part-time
Full-time
Degree level
Required language
English (Fluent)

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Description

AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (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 and only medical device to receive FDA approval for the treatment of long standing persistent Afib. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

POSITION SUMMARY:

The Director, Corporate Compliance, EMEA, will manage the corporate compliance program for AtriCure Europe, B.V., which operates throughout Europe, the Middle East and Africa (EMEA). In this role, you will lead the corporate compliance program to ensure business practices and activities of AtriCure and its business partners throughout the EMEA are in compliance with related AtriCure internal policies, local laws and regulations, relevant industry standards (e.g., the MedTech Europe Code of Ethical Business Practices), and applicable US laws, with the focus on laws, rules, regulations and standards concerning anti-corruption, privacy, data protection, healthcare provider interactions, transparency, and promotion of medical devices. You will serve as a strategic business partner for management and coach towards all covered employees, to assure that the company culture of compliance is a natural element in day-to-day business. Position is located in Amsterdam.

ESSENTIAL FUNCTIONS OF THE POSITION:

This description outlines the major recurring responsibilities of the position and is not intended to be all-inclusive. Other related job objectives, special assignments and less significant responsibilities will typically be expected of you. Your main responsibility will be to partner with company executive leadership to ensure that the compliance program effectively prevents and/or detects violations of law, regulations, policies, or the AtriCure, Inc. Code of Conduct for the EMEA region by:

  • Translating global compliance strategies and corporate compliance initiatives into regional level strategy based on appropriate regional needs, goals and objectives, taking into account local external regulatory trends and environment
  • Monitor developments and changes in best practices and regional regulatory and legislative requirements to advise the wider organization on necessary organizational changes. Interface with legal counsel regarding healthcare and privacy compliance requirements and interpretation
  • Serve as a point of contact for due diligence reviews for distributors in EMEA and act as an ambassador for the compliance program by coordinating with other functions during the review process
  • Assist in drafting, reviewing, revising, and implementing Ethics and Compliance corporate policies and procedures for the EMEA region, and lead development of any necessary country-specific variations
  • Stimulate and contribute to innovative approaches towards interactions with healthcare professionals and government officials in a manner consistent with AtriCure corporate guidelines and framework
  • Work closely with the AtriCure corporate office and third parties to shape and influence the business environment and industry codes of conduct
  • Provide and coordinate appropriate guidance, education, training, and regular communications on healthcare and privacy compliance to all covered employees
  • Conduct self-assessments and risk assessments to detect process deficiencies, and make recommendations for addressing the identified deficiencies
  • Develop and implement a healthcare and privacy compliance monitoring and auditing plan for the EMEA region
  • Coordinate preparations for and execution of corporate internal audits, as well as external audits and assessments
  • Monitor outstanding management action plans for the EMEA region and guide business partners to correct gaps with timely implementation corrective actions
  • Conduct investigations of non-compliance and escalated allegations, as appropriate, and document outcomes
  • Other duties as assigned by the Chief Legal & Compliance Officer.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

  • Regular and predictable worksite attendance [remove for field-based jobs]
  • Ability to work under fast-paced conditions
  • Ability to make decisions and use good judgment
  • Ability to prioritize various duties and multitask as required
  • Ability to successfully work with others
  • Additional duties as assigned

BASIC QUALIFICATIONS:

  • Bachelor of Arts or Bachelor of Science
  • Minimum of 7-10 years of health industry experience, with an extensive history in compliance and/or managing clinical operations in either pharmaceutical or medical device companies
  • Experience as a senior compliance professional at an international life sciences company
  • Good command of English
  • High integrity and professional ethics standards are a must
  • Knowledge of the GDPR and national data protection and privacy laws
  • Strong organizational, interpersonal, and analytical skills, as well as written and verbal communication
  • 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
  • Committed team player while taking initiative to get results with minimal supervision

PREFERRED QUALIFICATIONS:

  • Advanced degree in business, law or compliance
  • Current CCEP-I (Certified Compliance & Ethics Professional – International), CIPP (Certified Information & Privacy Professional) or equivalent
  • Varied work experience includes two or more areas of compliance, finance, audit, sales and marketing, legal or regulatory affairs in the life sciences industry
  • Familiarity with international anti-bribery and corruption compliance programs, ideally with experience working in an international (US headquartered) organization
  • Experience in project management a plus
  • Prior experience as GDPR Data Protection Officer highly valued
  • Ability to comprehend and interpret legal documents would be an advantage

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).

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 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, 15 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/benefits

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 and only 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, with more than 150,000 implanted to date.

Healthcare
Amsterdam
750 employees