Regulatory Affairs Specialist

6 days ago

Irving, Texas, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

Job Summary

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices and software products.

Key Responsibilities
  • Participate as the regulatory functional product team member for the organization's Transfusion Medicine regulatory team.
  • Support necessary regulatory activities required for product market entry and on-market support of instrument hardware and software.
  • Work with Regulatory and CFT to improve efficiency in regulatory deliverables.
  • Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to determine regulatory strategies for approval/clearance/registration for International and US markets for new products in development.
  • Survey the organization's country-specific regulatory experts to obtain country-specific regulatory feedback during product development and at the request of the core functional product team.
  • Support Compliance Team in internal and external audits.
  • May prepare documentation needed for registration worldwide or may oversee such preparation.
  • Assist in SOP development and review. Provide regulatory input to product lifecycle planning.
  • Determine and communicate submission and approval requirements to the core functional product team.
  • Participate in risk benefit analysis for regulatory compliance.
  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
  • Compile; prepare; review and submit regulatory submission to authorities (US and International).
  • Monitor impact of changing regulations on submission strategies.
  • Monitor and submit applicable reports to regulatory authorities.
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
  • Assess external communications relative to applicable regulations.
  • Review Advertising and Promotional material for compliance against regulatory requirements.
  • Assist with label development and review for regulatory compliance before release.
  • Review product changes to determine the type of change and submission requirements.
  • Analyze the input of cumulative product changes to current product submissions.
  • Ensure product safety issues and product-associated events are reported to U.S. regulatory agencies.
  • Provide regulatory input for product recalls and recall communications.
  • Assess export requirements for products labeled for research or investigational use.
Requirements
  • Bachelor's degree in science (e.g., biology, chemistry, biochemistry, microbiology, immunology, medical technology, pharmacy/pharmacology, nursing, engineering), or another medically related field.
  • Minimum 3-4 years experience in a regulated industry (e.g., medical devices, pharmaceuticals).
  • 2-3 years of experience in regulatory, but may consider quality assurance, research and development, product support, scientific affairs, operations, or related area.
Preferred Qualifications
  • Master's degree in regulatory affairs may be considered in lieu of direct regulatory experience.
  • Advanced degree in a technical or medically related area.
  • Regulatory Affairs Certification (RAC).
  • Experience writing, compiling, and submitting FDA submissions (e.g., 510k, PMA, BLA).
  • Experience supporting device hardware and software.
About Us

Abbott Laboratories is an Equal Opportunity Employer, committed to employee diversity. We offer a comprehensive benefits package, including medical coverage, retirement savings plan, tuition reimbursement, and education benefits.

The base pay for this position is $72,700.00 – $145,000.00, depending on location.

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