Lead Regulatory Affairs Consultant

2 weeks ago

Irving, Texas, United States Abbott Full time

Abbott stands as a prominent leader in the healthcare sector, dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of transformative technologies encompasses various healthcare domains, including diagnostics, medical devices, nutritionals, and branded generic medicines. With a workforce of 114,000 professionals, we cater to the needs of people across more than 160 nations.

Position Overview: Senior Regulatory Affairs Specialist

About Abbott

At Abbott, you will engage in meaningful work, experience personal and professional growth, and enjoy a fulfilling life. We offer:

  • Opportunities for career advancement within a global organization.
  • Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.
  • A robust retirement savings plan with significant employer contributions.
  • Tuition reimbursement, along with programs aimed at alleviating student debt and facilitating higher education.
  • A workplace recognized globally for its outstanding employee experience and diversity initiatives.

Role Responsibilities:

In this role, you will:

  • Act as a key member of the regulatory product team within the Transfusion Medicine sector.
  • Facilitate essential regulatory processes for product market entry and ongoing support of both hardware and software.
  • Collaborate with Regulatory and cross-functional teams to enhance the efficiency of regulatory deliverables.
  • Conduct thorough evaluations of regulatory histories to formulate strategies for product approvals in both international and U.S. markets.
  • Gather insights from country-specific regulatory experts to inform product development.
  • Assist the Compliance Team during internal and external audits.
  • Prepare and oversee the necessary documentation for global product registrations.
  • Contribute to the development and review of Standard Operating Procedures (SOPs).
  • Communicate submission requirements to the core product team effectively.
  • Engage in risk-benefit analyses to ensure regulatory compliance.
  • Review and submit regulatory documentation to authorities.
  • Monitor the implications of evolving regulations on submission strategies.
  • Maintain oversight of applications under regulatory review and communicate progress to the team.
  • Negotiate with regulatory authorities to secure submission approvals.
  • Evaluate external communications for regulatory compliance.
  • Review promotional materials to ensure adherence to regulatory standards.
  • Assist in the development and compliance review of product labels.
  • Analyze product changes to determine submission requirements.
  • Ensure timely reporting of product safety issues to U.S. regulatory agencies.
  • Provide regulatory insights for product recalls and associated communications.
  • Assess export requirements for research or investigational products.
  • Actively participate as a team member, contributing to team objectives and strategies.

Qualifications:

To be considered for this position, you should possess:

  • A Bachelor's degree in a scientific discipline or a related field.
  • A minimum of 3-4 years of experience in a regulated industry.
  • 2-3 years of experience in regulatory affairs or related areas.

Preferred Qualifications:

Ideal candidates may also have:

  • A Master's degree in regulatory affairs or a related field.
  • Regulatory Affairs Certification (RAC).
  • Experience with FDA submissions.
  • Experience in supporting device hardware and software.

Abbott is an Equal Opportunity Employer, committed to fostering a diverse workforce.

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