The Medical Devices segment produces a broad range of innovative products used primarily by health care professionals in the fields of orthopaedics, neurovascular, surgery, vision care, diabetes care, infection prevention, cardiovascular disease, sports medicine, and aesthetics. This segment is comprised of our Global Medical Solutions, Global Orthopaedics and Global Surgery Groups.
Healthcare Compliance (HCC) Specialist
The Health Care Compliance Specialist manages Healthcare Compliance programs transactions for the Medical Devices and Consumer Medical Devices in Czech Republic, Slovakia and Hungary. He or she supports planning, trainings, assessments, testing, monitoring and other varied HCC functions. This person is also responsible for maintaining existing programs and implementing activities related to Management Action Plans.
- Organizing and implementing training
- Maintain employee certification and training attendance records
- Assisting in HCC reviews and approvals
- Carrying out day-to-day tasks such as data collection, analysis and reporting,
- Supporting new procedure harmonization and implementation
- Assisting in software support for HCC software
- Assist in the harmonization, preparation, updating and implementation of all HCC written policies and procedures on an ongoing basis,
- May serve as the first line of communication to the business for reviewing local requests and documentation.
- Assist in implementation of modifying regional global strategies into regional and local level and where needed sector level, based on appropriate local needs, goals and objectives, taken into account local external regulatory trends and environment
- Support Implementation of Cluster strategy & plan aligning with the businesses and J&J Office of Compliance
- Support the HCC operations group in implementation of education, training, and regular communications on HCC to all covered employees, including local sales, marketing, finance, HR, managers, supply chain and directors at the local level
- Support the HCC Officer in the self-assessment and risk assessment processes to detect process gaps & inconsistencies
- Support the implementation of local testing & monitoring plan to demonstrate that the HCC program is effective and participate in execution where appropriate
- Assisting in coordinating preparations for Corporate Internal Audits
- Assist in the implementing and following up on the Management Action Plan as assigned by the HCC Officer
- Report unplanned deviations and supporting the HCC Officer in Managing day-to-day inquiries, allegations and investigations
- Implement the escalation process for serious allegations, as appropriate
- Collect and Provide metrics to the HCC Officer and Operations group as assigned
- Develop and conduct training for internal and external parties
- Liaise with legal department and external advisors
- Lead HCC projects and participate in regional or cross-sector projects
- Execute monitoring activities
- Partnering with the Global/Regional Operations team to:
- Implement business specific policies and SOP's and customize global/regional policies & procedures and education & training materials to reflect local requirements
- Implement IM systems that collect, audit, analyze, and report compliance information
- Deploy policies and procedures that align and monitor company activities to ensure compliance with government, private, legal and company HCC standards
- Implement HCC training programs, including new employee orientation, periodic training on specialized subjects, and annual refresher training
- Execute Testing & Monitoring plans and programs
- Ensure external reporting requirements are met per local regulations
- Ensure internal reporting requirements are met per enterprise requirements and schedule
We’d love to hear from YOU, if you have:
- BA/BS, advanced degree or equivalent preferred and a minimum of 2 years business experience. Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, Pharmacovigilance, Regulatory or Auditing
- Requires strong communication, organizational and analytical skills
- Proven track record in delivering results, self-starter and ability to manage complexity a must
- Industry related experience preferred: Medical Device or Pharmaceutical industries.
- Ability to manage conflicts in an open and constructive manner
- Strong analytical skills, strong influencing skills, ability to deal with complexity, strategic and tactical thinking
- English proficiency is a must, and native Hungarian
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
- Many opportunities to work on challenging projects and assignments.
- Possibilities for further personal as well as professional development.
- Many employees benefits.
Johnson & Johnson Kft. (7160)