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Regulatory Compliance Specialist

hace 1 mes


Ciudad Juarez, México Johnson & Johnson A tiempo completo

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 in this for life.

We are changing the trajectory of human health, YOU CAN TOO.

**We are searching for the best talent for Regulatory Compliance Specialist to be in Ciudad Juarez, Mex.**

**Purpose**:
The Regulatory Compliance Specialist, under the supervision of the Regulatory Compliance Engineeror the Regulatory Compliance Manager, provides support to maintain the complianceprogram 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 departmentaland 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 plan

Compliance:
Responsibilities may include, but are not limited to:

- Supports Internal and External AuditMetrics 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 Reviewand Data Review Boardactivities.

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** Qualifications and requirements**:

- 2 years of experience in Quality Assurance functions.
- Bachelor’s Degree
- Auditing Experience is preferred
- 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

**Primary Location**
Mexico-Chihuahua-Juarez
- **Organization**
E.E.S., S.A. de C.V. Mexico (8283)

**Job Function**
Quality

**Requisition ID**
2206062136W