Med-Tech Manager, Source Regulatory Compliance

Detalles de la oferta

.Ethicon, Inc. (Johnson & Johnson subsidiary) is recruiting for a **Med-Tech** **Manager, Source Regulatory Compliance**, located at an Ethicon site in one of the following locations:- **Raritan, NJ**:- **San Angelo, TX**:- **San Lorenzo, PR**:- **Cornelia, GA**:- **Cincinnati, OH**:- **São Paulo, Brazil**:- **Juarez, MX**:- **Norderstedt, Germany****Key Responsibilities**:- Partner with team members (e.G., Source Quality, Source, Franchise Quality, Quality Systems, Manufacturing, and other business functions.)- Proactively engages with suppliers to develop a robust Supplier Audit Response.- Tracks action plans to closure and issues Follow Up Reports in accordance with procedural requirements- Drive compliance performance improvement of suppliers by identifying capability challenges and working with Source Quality in the development of quality improvement plans.- Ensures execution of purchasing controls for suppliers- Supports the creation of strategic quality and compliance goals, assure management oversight and governance, and drive organizational capabilities to build compliance expertise and guidance.- Provide periodic data and analytics to our business partners- Assures compliance with regulatory requirements and internal Johnson and Johnson and Medical Device procedures by supporting Internal and External Audits- Ensures and maintains a state of inspection readiness for records within area of responsibility.- Provides visibility on new Health Authority regulations or changing expectations**Qualifications****Education**:- A minimum of a Bachelor's degree in Business, Life Science, Physical Science or Engineering required; Master's Degree preferred.**Experience and Skills**:**Required**:- A minimum of six (6) years of related work experience- Experience in Regulatory, Compliance, Quality Management and/or Operations in Medical Devices, or pharmaceutical environment- Outstanding communication (written and verbal), persuasion and leadership skills. Ability to listen, learn, guide, and think strategically are traits that are required for success in this role- Ability to connect, influence and effect change- Ability to engage senior management in identifying critical needs and to ensure effective deployment across the sector- Able to work remotely and partner globally- Ability to lead and influence others in a complex organization- Ability to drive an effective multi-functional, diverse environment- Must be fluent in English- Experience in establishing and maintaining external/supplier relationships**Preferred**:- Experience in actively participating in FDA or other Health Authority inspections**Other**:- Up to 25% travel- The anticipated base pay range for the position is $97,000 to $193,000.- The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

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