Medical Regulatory Officer
2 weeks ago
At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 250,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world’s leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.
**Job Summary**
Responsible for defining and assisting in deployment of policies and procedures pertaining to regulatory requirements and standards.
**Job responsibilities**
- To ensure functional management and business management is aware of and understands the principles and expectations associated with the applicable regulations.
- Acting as a facilitator to site management in the standardization and simplification of the standards.
- Performing and documenting comprehensive risk assessments relating to regulatory affairs
- Prepare packages for NMPA submission.
- Assist and support when necessary, in the development creation and documentation of world class quality and business system improvements, as well as support for customer and/or ISO/FDA/NMPA escalations as needed.
- Solicit ongoing feedback from business units for effectiveness of regulatory support.
- Coordinate activities of medical initiatives as required and keep focused on times of crises.
- Coach and mentor, the site to deliver regulatory affairs excellence to internal and external customers.
- Evaluates and schedules appropriate training programs and/or seminar for new/update regulation requirements,
- Coordinate existing and future plant wide Quality System Improvement and certification programs,
- Maintain good communication and relations with government.
- Develop document control and record control processes and lead Document Control Center to comply with related procedures.
- Must follow RBA and site EHS requirements.
- Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.
- Comply and follow all procedures within the company security policy.
- May perform other duties and responsibilities as assigned, e.g. other ISO standard.
- Understand and comply customer requirements and medical devices regulatory.
- To ensure FDA compliance e.g. 21 CFR Part 820
- Monitoring and measure medical KPIs and follow-up 4Q report for improvement.
- Appointed as SME to compile the QMP record.
- Assist and verifying validation report (IQ, OQ & OP) in GDP practice.
**Other responsibilities**:
Additional job as assign by superior.
Ability to lead team and interact with all levels of management in a matrixed and political environment.
Consulting skills with emphasis on customer acceptance, training, and partnering.
**Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.
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