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Manager/Sr. Manager, Regulatory Affairs (Remote or Hybrid)

Company: US01 Illumina, Inc.
Location: San Diego
Posted on: September 24, 2022

Job Description:

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world-changing projects, you will do more and become more than you ever thought possible.

The Manager/Sr. Manager, Regulatory Affairs (RA) will be an instrumental member of the Regulatory Affairs team supporting IVD product development teams, U.S. and international submissions and technical documentation, advertising and promotion review, change management, and regulatory compliance. The incumbent will Interact with various corporate functions and provide regulatory guidance as needed. Write and implement regulatory procedures for continuous improvement. You will be responsible for ensuring timely and effective assessments of new regulatory information to determine impact on Illumina products and processes.

Responsibilities:

  • Represents the RA function on assigned cross-functional project teams.
  • Interprets and applies regulations by creating regulatory strategies.
  • Develops and executes regulatory plans for complex projects including new products and maintenance of approvals/licenses/authorizations for existing marketing authorizations.
  • Prepares hardcopy and electronic information packages for submission to regulatory agencies.
  • Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance.
  • Reviews validation, clinical and stability protocols and reports for regulatory submission soundness.
  • Assesses manufacturing process and labeling through change control for regulatory reporting impact and compliance to regulations.
  • Defines, monitors and receives deliverables for submissions.
  • Writes and/or edits submission documents using regulatory templates, or creates new templates.
  • Assembles paper and/or electronic copies for submission.
  • Monitors new and revised regulatory requirements; disseminates information as directed by management.
  • Interacts with regulatory agencies and third party accrediting bodies.
  • Prepares internal procedures for continuous process improvement.
  • Mentors junior members of the department.
  • Provides regulatory guidance and/or training to external departments and partners.
  • Assists with resource planning and budgeting as needed.
    Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

    Requirements:
    • Experience with an in vitro diagnostics device multi-nation company required; pharmaceutical, biologics or medical device companies as alternative.
    • Strong understanding of CFDA regulations required; other international requirements - EU, Canada, Australia, Japan and Korea - preferred.
    • Demonstrated ability to work independently with new, complex technologies and produce professional work products.
    • Strong written and verbal communication skills.
    • Team leadership skills preferred.
    • Familiarity and ability to work with office automation programs and corporate database tools.
    • Strong work ethic and demonstrated ability to deliver assignments on time.
      Experience/Education:
      • Requires Bachelor's degree or equivalent, may require an advanced degree, in healthcare, diagnostics or related field
      • Additional coursework in regulatory or quality strongly desired.
      • Managers at this level may become involved in day-to-day activities where their acquired expertise and knowledge provide focus to subordinates.
      • Uses interpersonal skills to influence customers, suppliers and other comparable level managers.
      • Manager level: Typically has 7+ years of direct work experience
      • Sr. Manager level: Typically has 12+ years of direct work experience
        #LI-REMOTE

        Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, Illumina may require proof of COVID vaccination in accordance with local statutory requirements (subject to limited exceptions) beginning November 1, 2021.

        At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

Keywords: US01 Illumina, Inc., San Diego , Manager/Sr. Manager, Regulatory Affairs (Remote or Hybrid), Executive , San Diego, California

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