Johnson & Johnson is recruiting a Health Care Compliance Officer (HCCO) Medical Devices covering Austria and Switzerland, based out of our Solothurn offices in Switzerland
The HCCO, drives the Healthcare Compliance (HCC) programs for the J&J Medical Austria and Switzerland organisations to ensure business practices and activities follow related J&J internal guidelines, laws, regulations and industry codes (MedTech Code) and anti-corruption laws including the Foreign Corrupt Practices Act.
As the HCCO, you will serve as a strategic business partner for management and act as a coach for all covered employees assuring a company culture of compliance is a natural element in day to day business. You support planning, trainings, assessments, testing & monitoring and other HCC activities for Medical Devices in the countries. Externally you will liaise with the national compliance associations and MedTech as required.
This position reports to the HCCO MD for Midsize Markets.
- Partner with company executive leadership to ensure the HCC program efficiently prevents and/or detects violations of law, regulations, policies, or the Code of Conduct by:
- Establish & chair Compliance Committees responsible for creating and implementing effective compliance programs and key decision making for the countries.
- Communicate on the status of the program regularly to the line manager and the relevant board(s)
- Translate global HCC strategies into country level strategies based on appropriate needs, goals and objectives, taking into account local external regulatory trends and environments. Develop and coordinate implementation of country strategies, aligning with the businesses and J&J HCC.
- You will work with Government Affairs, Regulatory, Legal, and external organisations (primarily trade associations) to shape & influence the environment and industry codes of conduct
- Proactively cooperate with functions close to HCC like Legal, Privacy, Regulatory and Quality Management
- You will ensure adequate representation in relevant business governance structures e.g. management board and establish discussion platforms to get general business consensus and impact analysis
- Stimulate and contribute to innovative approaches towards HCPs and GOs consistent with the HCC/HCBI guidelines and framework and performing business plan reviews
- Ensure disclosure requirements of MedTech Europe and local legislation are met.
- Provide and coordinate appropriate guidance, procedures, education, training, and regular communications on HCC to colleagues including Affiliate/General Managers, Management Boards etc.
- Conducting self-assessment and risk assessment processes to detect process gaps & inconsistencies
- Coordinate the establishment of the Management Action Plans, guiding business partners to close gaps and implement corrective actions
- Developing a testing & monitoring plans to demonstrate that the program is effective and participate in execution where appropriate. Engage Affiliate/ Board participation in roll out
- Coordinating preparations for Corporate Internal Audits
- Consults on HCC matters, policies and procedures to business stakeholders. Perform HCC reviews & approvals for HCP/HCO/GO related activities as required.
- Participating in and leading investigations of non-compliance and implementing the escalation process for allegations, as appropriate
- Collaborate cross sector to ensure alignment through participation in cross sector council
- Partnering with the Global/Regional Operations team
- Interface with legal counsel and privacy regarding HCC and Privacy requirements and interpretation
- University/Bachelor Degree or equivalent
- Minimum of 5 years business experience. Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, or Regulatory. Prior experience in project management is required.
- Knowledge of regulations and industry standards of the Medical Devices market (i.e. MedTech Code). Knowledge of laws, regulations and industry standards for the country is also required.
- Experience in Health Care Compliance would be valued.
- Requires good communication, organization and analytical skills
- Ability to cultivate meaningful relationships and lead internal collaboration across the company, influencing business decisions and business partners across all functions and levels of the business
- Ability to take complex business situations and develop solutions to ensure compliant growth is achieved
- Consistent track record in delivering results.
- Ability to work independently and in a detailed manner
- Committed team player
- Understands and masters the J&J Credo based culture.
- Ability to comprehend and interpret legal documents would be an advantage
- Local language a requirement with additional good command of English. Additional knowledge of French and Italian would be preferred
- Travel percentage – up to 10%
Synthes GmbH (7111)