Regulatory Affairs Manager
Requisition Number: 205636
Work Location: Guadalajara, Jalisco
Participates in system and device product development teams to ensure regulatory, quality, and safety standards are incorporated into product specifications and manufacturing processes.
Essential Duties & Responsibilities
– Works with customers and Business Units to create 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.
– Coordinates regulatory compliance aspects of product launch.
– Collaborates with the customer and internal engineering teams to continuously improve engineering services and regulatory compliance of the devices manufactured.
– Identifies and ensures compliance with all laws and regulations that apply to medical device manufacturers.
– Provides fellow employees and customers with guidance and support to ensure compliance with cGMP and the QSR.
– Supports internal, external, and regulatory audits with the FDA.
– Helps define and develop regulatory, quality, and safety training for the plant.
Education & Experience Requirements
– Bachelor’s degree in relevant scientific, healthcare, engineering or other related field.
– Plus 5 to 8 years of progressive experience in the medical device industry with an emphasis in regulatory affairs, preferably in a 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 3 medical device experience. ISO 13485 and QSR experience required.