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Med-tech Manager, Source Regulatory Compliance
hace 3 semanas
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. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
- Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
**Primary Location**
United States-New Jersey-Raritan-1000 US HIghway 202
**Other Locations**
Europe/Middle East/Africa-Germany-Schleswig Holstein-Norderstedt, Latin America-Brazil-São Paulo, Latin America-Mexico-Chihuahua-Juarez, North America-United States-Ohio-Cincinnati, United States-Puerto Rico-San Lorenzo, United States-Texas-San Angelo, United States-Georgia-Cornelia
**Organization**
Ethicon Inc. (6045)
**Job Function**
Quality
**Requisition ID**
2206086263W
