Regulatory Affairs Specialist

About the Company

Abbott 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. Our 115,000 colleagues serve people in more than 160 countries.

About the Role

This Regulatory Affairs Specialist will work out of our Pleasanton, CA location in the Heart Failure Division. As an individual contributor in the function of a Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department. With limited supervision, you will execute tasks and partner across business functions to support product registration and regulatory activities.

Responsibilities

• Execute product registration submissions, change order management, and progress reports.
• Interact with regulatory affairs team members and other cross-functional teams for regulatory submissions, product licensing, and relevant documentation.
• Support the product release process by creating GTS licenses or reviewing and approving requests for product release.
• Serve as a regulatory liaison throughout the product lifecycle.
• Ensure timely approval of medical devices and continued approval of marketed products.
• Interface with regulatory agencies as needed.
• Conduct reviews of product and manufacturing changes for compliance with applicable regulations.
• Create, review, and approve engineering change orders.
• Review protocols and reports to support regulatory submissions.
• Support all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees.

Requirements

• Bachelor's Degree (± 16 years), Technical discipline preferred OR an equivalent combination of education and work experience.
• No experience required; some experience with the medical device industry preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others in accomplishing projects.
• Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes, and meets deadlines in a timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Preferred Qualifications

• Master’s Degree (± 18 years) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
• 2 years of experience in a regulated industry (e.g., medical products, nutritionals), preferably in a regulatory area but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Regulatory knowledge of:
  • Regulatory history, guidelines, policies, standards, practices, requirements, and precedents.
  • Regulatory agency structure, processes, and key personnel.
  • Principles and requirements of applicable product laws.
  • Submission/registration types and requirements.
  • GxPs (GCPs, GLPs, GMPs).
  • Principles and requirements of promotion, advertising, and labeling.
• Communication skills or ability to:
  • Communicate effectively verbally and in writing.
  • Learn to write and edit technical documents.
  • Work with cross-functional teams.
  • Work with people from various disciplines and cultures.
• Cognitive skills or ability to:
  • Pay strong attention to detail.
  • Handle detailed tasks and prioritize them.
  • Meet deadlines.
  • Think analytically and critically.
  • Review and analyze documentation.
  • Research and locate information on regulatory requirements and products.
  • Exercise judgment within defined procedures and practices to determine appropriate action.
  • Apply general knowledge of technical alternatives and understand their impact on the systems environment.
  • Apply business ethical standards.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit—an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Pay

The base pay for this position is $73,900.00 – $116,000.00. In specific locations, the pay range may vary from the range posted.