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Salary
$128k – $272k per year (Estimated)
Location
In office (Switzerland, Garching bei München)
Seniority
Architect
Employment
Full-Time
Overview
Company
Impact
Profile match
Edwards Lifesciences is an American medical device company that became independent from Baxter in 2000 but traces its work to the first commercially available artificial heart valve, developed by Miles Lowell Edwards in the late 1950s. It concentrates entirely on structural heart disease and critical care monitoring, and its transcatheter aortic valve replacement business changed cardiac practice by allowing valves to be delivered through a catheter rather than through open chest surgery. Headquartered in Irvine, California and listed on the New York Stock Exchange, it holds a leading position in a market it largely created.

Role purpose

This role provides pragmatic, business-focused compliance guidance and hands-on support to Edwards’ commercial, medical, and marketing teams across Europe’s Tier 1 markets (including Germany, France, UK/Ireland) and Canada. It supports the application of Edwards’ global business practices framework, particularly in relation to interactions with Health Care Professionals-while ensuring alignment with applicable local and regional healthcare laws, ABAC laws, regulations, and industry standards. The role also serves as the primary Compliance point of contact for one EU Business Unit and for key regional functional stakeholders.

By establishing strong, proactive relationships with business leaders at both Regional and local levels, this role acts as a strategic thought partner to Edwards’ business groups. It develops and implements compliance strategies that enable sustainable business success while upholding Edwards’ commitment to ethical conduct and patient wellbeing and actively manages Industry Association relationships.

Working closely with cross-functional partners including Legal, Human Resources, Regulatory, Internal Audit, and Finance, the role manages complex compliance matters in accordance with legal, industry, and internal requirements. It ensures clear, timely communication and escalation to appropriate functional and business leadership as needed.

How you will make an impact:

  • Act as a proactive business partner to relevant country team, Business Units and functions on Compliance topics to enable Company success. Set strategy by balancing compliance requirements with business exigencies and propose and implement pragmatic, lasting solutions. Support the EMEACLA Compliance VP on selected regional projects and initiatives.
  • Drive optimization of HCP-related policies, processes and systems by identifying gaps and issues, leveraging global best practices (internal and external), and developing, proposing and implementing effective solutions. Influence outcomes and drive resolution with business leadership.
  • Act as Compliance subject matter expert for defined topics and/or geographies (e.g. local compliance program; provide guidance on anti-kickback regulations and related requirements). Provide clear, practical guidance to enable compliant business decision-making and provide hands-on support on critical local compliance matters.
  • Drive and sustain a strong culture of compliance within the assigned region and role model Edwards’ compliance values and behaviors. Ensure appropriate governance around compliance matters, including active participation in compliance-related committees. Ensure strong alignment within EMEACLA and Global Compliance and effective cross-functional collaboration (Legal, HR, Finance, Internal Audit, Regulatory).
  • Conduct and analyze business-related compliance risk assessments. Support monitoring and auditing against policies and procedures, ensure timely execution of remediation plans, and support investigations into alleged misconduct or policy violations, ensuring consistent handling, outcomes, and corrective actions within the assigned region.

What you'll need:

  • Expert knowledge and understanding of Medical Device Industry policies, procedures, and guidelines relevant to compliance across Europe;
  • Knowledgeable of the European healthcare regulation rules and able to provide guidance on external procedures;
  • Experienced in analyzing, and developing business strategy from a competition and anti-kickback perspective;
  • Full professional work proficiency in English; German and French language is a strong plus;
  • Expert understanding of effective compliance program standards;
  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization;
  • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives;
  • Expert understanding of procedures with extensive and detailed knowledge of company allows for innovative concepts and promoting new ideas
  • Ability to support and solicit input from team members at all levels within the organization
  • Strict attention to detail
  • Excellent facilitation and presentation skills
  • Proven successful project management skills
  • Adhere to all company rules and requirements
  • Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of compliance to the business
  • Ability to influence the business to adopt new industry requirements seamlessly
  • Ability to develop relationships and leverage them to influence change
  • Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment
  • 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 provide leadership and direction to cross-functional teams to successfully implement compliance related solutions

What else we look for:

  • Bachelor's Degree in related field or previous related experience in legal, and/or health care compliance
  • Master's Degree or equivalent in related field or previous related experience in legal, and/or health care compliance
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