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Principal Regulatory Compliance Specialist
hace 3 meses
At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in 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 Move Could Mean Our Next Breakthrough.
At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.
In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.
We are changing the trajectory of human health, YOU CAN TOO.
We are searching for the best talent for
Principal Regulatory Compliance Specialist (Temporary 24 months) to be in Juarez.**
Porpose:Manages the internal audit program, executes audits to verify compliance with regulations and applicable international standards as well as company policies and procedures related to the Quality System. Give guidance or advice to the organization as it relates to compliance, when required. Host External audits from Regulatory Agencies, Notified Bodies, and Enterprise Regulatory Compliance
You will be responsible for:
- Manages the internal audit program and makes sure it complies with applicable regulations and standardsoAssures adherence to audit schedule
- Executes internal audits personally to evaluate compliance of the quality system with applicable regulations, standards and company policies and procedures
- Schedules re audits of deficient elements of the quality system as required
- Ensures adequate responses to internal audit observations
- Monitors effectiveness of corrective and preventive actions implemented as a response to audit observations
- Prepares and host external audits from Regulatory Agencies, Notified Bodies and Enterprise Regulatory Compliance
- Responsible for external audit readiness activities
- Provides daily and closure communication on external audits
- Reviews and assures that responses to external audit observations are adequate
- Drives compliance with internal audit metrics
- Provides the organization with compliance information such as trends, audit results and metrics reporting at different forums such as management review
- Executes training and evaluation for internal auditors as applicable
- Escalates compliance issues in accordance with established procedures
- Provides compliance training to different functions within the organization as applicable
- Advises the organization and participates in creating policies and procedures that are in compliance with applicable Regulations and Standards
- Participates in creating and maintaining the budget for the compliance activities
- Support implementation of new external standards/regulations.
- Review and disposition document changes within areas of expertise per applicable procedures.
Qualifications:
Qualifications and requirements:
- BS in science, engineering, or business.
- MBA or Master's in Science, preferably.
- Minimum 8years of experiencein Quality, Regulatory Compliance,or related activities preferably in Medical Devices field or in Pharmaceuticals
- Lead Auditor Certification by an accredited organization preferred.
- Knowledge on applicable Standards and Regulations applicable for the MD sector preferred.
- Excellent communication skills, able to quickly build credibility within the Compliance community, executive management, external regulators, and industry.
- Strong collaboration and influence management skills to partner effectively with Sector functions and across Operating Units
- Strong collaboration skills across the organization and at all levels
- Balanced technical understanding of products and processes combined with superior business and compliance acumen
- Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results
- Ability to recognize, build support for change and engage in constructive conflict.
- High tolerance for ambiguity in a complex environment
- Ability to make the complex clear and easily understood by others
- Ability to build partnerships both internally and externally
