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Principal Regulatory Compliance Specialist
hace 3 meses
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That’s why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. Every day, our more than 140,000 employees across the world are blending heart, science, and ingenuity to profoundly change the trajectory of health for humanity.
Diversity, Equity & 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 MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.
**We are searching for the best talent for PRINCIPAL REGULATORY COMPLIANCE SPECIALIST to be in CIUDAD JUAREZ.**
**PURPOSE**:
The Regulatory Compliance Specialist, under the supervision of the Regulatory Compliance Engineer or the Regulatory Compliance Manager, provides support to maintain the compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures, and J&J Corporate requirements.
**YOU WILL BE RESPONSIBLE FOR**:
Responsibilities may include, but are not limited to:
Works under limited supervision with responsibility to make compliance administrative decisions to meet departmental and internal/external customer needs
Demonstrate a thorough knowledge of facility and organizational policies and procedures
Interacts with Quality Department and provides support to site and corporate initiatives
Provides periodic reports, completes special assignments and assists supervisor, as assigned
Generate reports of each department progress and present to the appropriate management along with recommendations for improvement as required.
Originates procedure changes and performs implementation tasks
Maintains necessary supplies and equipment.
Support and promote the quality, safety and industrial hygiene objectives of the plant.
Compliance:
Responsibilities may include, but are not limited to:
Supports Internal and External Audit Metrics monitoring and scorecard maintenance
Supports/participates in External Audit/Inspection Readiness Activities
Supports Site Internal Audit Program and performs internal audits according to the established internal audit procedures.
Coordinates and assists in the development of training programs of all types and levels. Provides training in QSR, ISO and other regulations, standards and quality concepts.
Supports Site Management Review and Data Review Board activities
Other tasks
Performs a variety of other duties of a complexity commensurate with the Job Level as assigned or required.
Comply with all environmental, safety and occupational health policies.
Comply with the Quality System regulations, standards, company policies and procedures.
**Qualifications**:
**REQUIREMENTS**
**EDUCATION: **
High School Diploma as minimum
Bachelor’s Degree, preferred
**EXPERIENCE: **
6 - 8 years of related experience.
Auditing Experience is preferred
**ADDITIONAL REQUIREMENTS: **
Computer Literate. Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
Good written and oral communication skills as well as report writing, presentation and training skills both in English and Spanish.
Accomplishes objectives in a timely manner with limited or without day to day supervision.
Good interpersonal skills; customer service oriented.
Working knowledge of FDA/ISO/Health Authority Quality System regulations and standards.
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