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Medical Regulatory Officer

Req ID: J2369427-IL

  • Ubicación
    Sungai Petani, Kedah, Malaysia
  • Categoría Grupo de Calidad
  • Publicado viernes, 11 de agosto de 2023
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

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.

Descripción del Trabajo

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 identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.

BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact your local police department. Any scam job listings should be reported to whatever website it was posted in.

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