Regulatory Affairs Specialist II â Structural Heart

2 months ago

Santa Clara, United States Abbott Laboratories Full time

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • 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 bachelorâs 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.

Structural Heart Business Mission: why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

The Opportunity

We are recruiting for a Regulatory Affairs Specialist II to join our team on-site in Santa Clara, CA.This new team member will support manufacturing/operations day-to-day activities for change control and provide regulatory direction on team activities. The individual will apply basic regulatory understanding to support of product and teams as well as prepare US/CE regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Additionally will handle regulatory activities involved in documentation, labeling, field support and apply regulatory and technical knowledge to a focused area of work assignments. This Specialist understands, implements, and maintains the quality policy and ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

What Youâll Work On

  • Verifies with supervisory staff and executes regulatory requirements in relation to product development, submissions, product maintenance, project plans.
  • Implements Division Regulatory Strategy in specific product related activities.
  • Basic understanding of laws and regulations.
  • Obtains supervisory input for interpretation leading to the solution of issues, and to product development and support.
  • Analyzes the input of cumulative product changes to current product submissions.
  • Shares knowledge with others in department and on teams.
  • Provides solutions to a variety of problems where analysis requires moderate degree of evaluation.
  • Prepares and aligns individual goals with department goals.
  • Establishes and executes against project goals and implements plans.
  • Provides input to establishing group plans and implementation of those plans.
  • Follows GMP guidelines and procedures.
  • Writes Effectively: Prepares written information in a clear and concise fashion, appropriately designed for varying target audiences.
  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • For products division-wide: Advises and communicates to project, group, or venture regarding basic regulatory strategies.
  • Signs-off at team level within delegated parameters for change control.
  • Release authority for labeling/sales/promotional materials.
  • Official correspondence with outside regulatory agencies are guided by supervisory staff.
  • Conducts basic negotiations on routine product related issues with government agencies.
  • Follows through on submission related activities to secure product approval.
  • Directs own daily activities by utilizing team goals and division regulatory priorities.
  • Provides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system.
  • Obtains supervisory regulatory review on submission documents prior to submission to government agencies.

Required Qualifications

  • Bachelorâs Degree or an equivalent combination of education and experience
  • 5 yearsâ work experience

Preferred Qualifications

  • Bachelorâs degree in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, engineering, etc.
  • 5+ yearsâ experience in Medical Device industry
  • 1-2 years of regulatory experience.
  • Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Communicate effectively verbally and in writing. 
  • Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
  • Think analytically with good problem-solving skills.
  • 510(k), PMA, or other international regulatory submission experience.
  • RAPS Certification. 

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.



The base pay for this position is $73,600.00 â $147,200.00. In specific locations, the pay range may vary from the range posted.

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