Head of Legal

hace 2 días


Poligono Industrial Alcobendas, España Cordis A tiempo completo

**Essential Duties and Responsibilities**:

- Compliance monitoring of business activities, medical events and Interactions with Healthcare Professionals (“HCP”) and Healthcare Organizations (“HCO”);
- Support the EMEA Head of Legal and Compliance to evaluate all activities that require compliance pre-approval before payment, ensure process transparency, documentation completeness and archiving;
- Deliver compliance related policy training, monitor and ensure continuous training;
- Support investigations on compliance concerns raised by management, employees or others;
- Ensures compliance with regulations and controls by examining and analyzing records, reports, operating practices, and documentation; recommending opportunities to strengthen the internal control structure
- Record retention for EMEA Legal & Compliance
- Audit of accounting and other records for the purpose of compliance audit with focus on key compliance risk areas, including:

- Payments to HCP and fair market value
- Local medical events
- Grants, sponsorship, donation and charitable contribution
- Fees to hospitals
- Transactions with HCO and medical associations
- Off label promotion
- Distributor and third party intermediaries due diligence
- Employee expense reports
- Internal Clients/Relationship:

- Frequent and significant, including corporate functional leadership, EMEA senior management, and EMEA employees, across all functions
- External Clients/Relationship:

- Occasional interaction with professional service providers and potentially with key customers/distributors, principals

**_
Additional responsibilities:_**
- Ensure the coordination of the records retention process for the EMEA Compliance department
- Responsible for communicating business related issues or opportunities to next management level
- For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets
- Performs other duties assigned as needed
- Support record Retention appropriately
**Education/Training and/or Experience**:

- University degree, business preferred, CPA, or CIA/ CISA/CFE or other equivalent
**Required Knowledge, Skills, Abilities and Certifications and/or Licenses**:

- Years of Work Experience: 6 years minimum
- Familiarity with the medical device industry, laws and regulations governing medical device manufacturers, and healthcare compliance
- Preferred Training/Technical Knowledge: Forensic auditing/investigation training, including technology use;
- Experience working for US-based company
- Required Language Skills: Verbal and written: English, Native language expert
**Additional Position Requirements**:

- Flexibility to Travel: 10 to 30%



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