DirecciónPrincipal Regulatory Compliance Specialist Technician At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose : to profoundly change the trajectory of health for humanity.
Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.
Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.
When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough. COMPANY Biosense Webster, Inc.
is recognized worldwide as a leader in the science behind the diagnosis and treatment of cardiac arrhythmias.
Guided by the needs of electrophysiologists and cardiologists, Biosense Webster has pioneered innovative technological advancements for more than 30 years.
Some might call this quite a heritage.
At Biosense Webster, we say it's just the beginning.
For more information, visit JOB RESUME Under direct supervision supports monitoring of Compliance Metrics and dashboard maintenance for different forums.
Also, supports Site Internal Audit Program and External Audit Readiness activities as required. RESPONSIBILITIES In accordance with all applicable federal, state and local laws / regulations and Corporate Johnson & Johnson, procedures and guidelines, this position :
- Supports monitoring of Compliance Metrics and dashboard maintenance to be presented in different forums.
- Supports the Site Audit Readiness Program, as required.
- Supports Site Internal Audit Program, executing internal audits, following up on completion of observation investigation, action, effectiveness monitoring plans or other as required.
- Support Compliance training education programs applicable to the organization.
- Ensure compliance with the Quality Policy in all activities.
- Interacts with all Department and provides support to company activities as required.
- Provides periodic reports, completes special assignments, as assigned.
- Creates procedure / document changes and performs implementation tasks as applicable.
- Supports and promotes the safety and industrial hygiene objectives of the plant.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Performs a variety of other duties of a complexity commensurate with the Job Level as assigned or required.
- Follow compliance regulations and standards applicable to the organization.
- Knowledge of Operating Procedures and related computer systems required.
- Responsible for communicating business related issues or opportunities to next management level.
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For those who supervise or manage a staff, responsible for ensuring 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, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
o Performs other duties assigned as needed.
QUALIFICATIONS AND REQUIREMENTS
- High School Diploma as minimum 6 to 8 years of experience or minimum
- Bachelor's or Degree in progress 0-2 Years of related experience minimum REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS / LICENSES and AFFILIATIONS*
- Computer Literate as Microsoft Office or similar.
- Good written and oral communication skills as well as report writing, presentation, and training skills both in English and Spanish.
- Accomplish objectives in a timely manner with limited day to day supervision.
- Good interpersonal skills; customer service oriented.
- Working Knowledge in Current Good Manufacturing Practices, Data integrity and all applicable Standard and Regulations and respective requirements applicable for the organization (preferred)
- Experience as Quality Systems Auditor (preferred).
