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Regulatory Affairs Manager (Remote)

Req ID: J2272214

  • Ubicación
    Clinton, MA, Massachusetts, United States of America
    Remoto - Estados Unidos, Florida, United States of America
  • Categoría Calidad Global
  • Publicado miércoles, 25 de agosto de 2021
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

Descripción del Trabajo


Act as focal point and subject-matter expert for all regulatory affairs activities. Participates in system and device product development teams to ensure regulatory, quality, and safety standards are incorporated into product specifications and manufacturing processes.


  • Acts as Regulatory liaison between the site and government agencies, authorized representatives and Notified Bodies.
  • Oversees and coordinates regulatory compliance aspects of product launch.
  • Provides fellow employees and customers with guidance and support to ensure compliance with regulatory standards and regulations.
  • Supports internal, external, and regulatory audits.
  • Leads development of  regulatory training for the site.
  • Identifies and ensures compliance with all laws and regulations that apply to medical device manufacturers.
  • Recruit, lead, coach, manage, RA Department staff.
  • Collaborates with the customer and internal engineering teams to continuously improve regulatory compliance of the devices manufactured.
  • Works with customers and Business Units to create Regulatory, Quality, and Manufacturing plans providing clear, unambiguous, and mutual understanding of responsibilities and requirements for Jabil service(s) provided.
  • Works with design and process engineers to develop risk assessments.
  • Supports sales presentations, contract reviews, and quoting.
  • Participate in planning long term/short term functions of the department to support Jabil.
  • 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.


  • Typically reports to Management.  Direct supervisor job title(s) typically include: Senior Quality Assurance Manager.
  • Job is responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).


  • Ability to effectively present information and respond to questions from groups of managers, clients, and customers.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to operate a personal computer including using a Windows based operating system and related software.
  • Advanced PC skills, including training and knowledge of Jabil’s software packages.
  • Ability to write complex correspondence.  Read and understand visual aid.
  • Ability to apply common sense understanding to complete complex regulatory submissions. 
  • Ability to deal with highly variable and fast-paced situations.
  • Ability to read and comprehend simple instructions, short correspondence, and memos.


  • Bachelor’s degree in relevant scientific, healthcare, engineering or other related field.
  • 5 to 8 years of progressive experience in the medical device industry with an emphasis in regulatory affairs, preferably in a medical device manufacturing environment.
  • Experience should include medical device safety and quality assurance, global regulatory affairs, and sterilization, as well as FDA audit experience, manufacturing, and Class I and II medical device experience.
  • Experience with private labeling a plus.
  • ISO 13485, MDD and QSR experience required.
  • Famliarity with MDR and CMDR.
  • Or an equivalent combination of education, training or experience.


  • Regular business hours.  Some additional hours may be required.
  • Travel requirements:  Domestic and/or Global, up to 15%
  • Climate controlled office environment during normal business hours.
This job cannot be performed remotely in the state of Colorado.
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