[emea] Head of Compliance

vor 3 Monaten

Genf GE, Schweiz Santen Vollzeit

**Company Description** Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.**

**PURPOSE OF ROLE**

This position will play a pivotal role in shaping the future of our Compliance Organization and advancing our commitment to integrity, compliance, and ethical conduct through building a proactive compliance department that not only meets regulatory requirements but also adds value to our organization by leading our team into a new era of partnership and proactive compliance. This position will redefine the role of compliance within our organization, shifting from a traditional regulatory oversight model to one characterized by collaboration, innovation, and proactive risk management.

The Compliance Officer will partner with members of the Executive Leadership Team to ensure compliance with industry, regulatory, and Company requirements, and advise the leadership team on how to mitigate potential risks.
- Develops and executes the **annual compliance risk assessment** to identify potential areas of compliance vulnerability and risk that analyzes the General Risk and Specific Risk in order to develop and implement activity specific action plans to address of problematic issues and provide general guidance on how to avoid or deal with similar situations in the future.
- Develops and maintains policies and procedures for the **general operation of the Compliance Program** and its related activities to prevent illegal, unethical, or improper conduct.
- Develop, coordinate, and document a **compliance training program** that focuses on the elements of the compliance program, and educates employees and management on pertinent laws, regulations, and compliance expectations at Company.
- Establishes a **communication plan and strategy** that promotes effective lines of communication and mechanisms for employees to speak-up and report compliance concerns and potential compliance violations
- Manages the **Compliance Hotline **and c**ollaborates closely with cross-functional colleagues** in Legal, Human Resources, Internal Audit, Regulatory and other core functions in order to direct compliance issues through the appropriate channels for investigation and resolution as well as work towards future improvements as the Compliance Program evolves.
- ** Investigate allegations of violations** of the company’s Code of Conduct and compliance policies and guidelines; conduct/coordinate investigations; communicate findings to the appropriate senior leadership and/or Executive Committees, as necessary. Assist in managing potential litigation and investigations related to the company’s compliance program. Establish and chair a local EMEA compliance committee to provide governance and evaluation of the company’s compliance program and any alleged violations of such program. Ensure proper reporting of violations to duly authorized enforcement agencies as appropriate or required.
- Establishes and executes a **compliance monitoring and auditing plan** to support ongoing evaluation of processes and related controls and to determine compliance with pertinent laws and regulations.
- Builds and **leads two diverse teams** of multi-disciplinary compliance professionals to execute the compliance strategy and plan. These teams consist of two distinct compliance functions:

- Corporate Compliance Assurance Team - Resources in these roles will be focused on driving centralized, coordinated development and enhancement of Compliance Program operational elements for the region
- Business Compliance Partner Team - Resources in these roles will focus on directing and coordinating front-line engagement and compliance risk management advisory support to the business.
- Regularly reports compliance matters to Company’s leadership and Compliance Committee and collaborates with Company’s Executive Leadership Team to establish methods and plans to address and mitigate compliance risks.
- **Medical Device Compliance**: Proven track record of building a Compliance Program that includes guidance, SOPs, training and monitoring, specific to Medical Device activities such as customer training programs, surgical interactions, products compliance (demonstration, replacement, evaluation, no charge, etc.), commercial transactions, and patient organization interactions.
- **Medical, R&D and Clinical Compliance**: Build compliance program activities related to the Medical, R&D and Clinical departments. This includes a deep understanding of activities such as MSL interactions, Medical Information Requests, Clinical trial elements, publications, Grants, protocols, and all other potential risks around the Medical, R&D and Clinical Organizations.
- **Middle E

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