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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- 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.
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
- 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).
JOB QUALIFICATIONS - KNOWLEDGE REQUIREMENTS
- 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.
JOB QUALIFICATIONS - EDUCATION & EXPERIENCE REQUIREMENTS
- 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.
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