Regulatory Affairs Specialist II - Structural Heart (on-site)

Abbott (abbottcareers2 board); Santa Clara (CA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Free medical coverage

Retirement plan with high employer_con

Tuition reimbursement

Job summary

Abbott Structural Heart regulatory affairs specialist position in Santa Clara, CA. This role focuses on preparing and submitting regulatory documentation to FDA and international agencies, ensuring compliance across product lifecycles.

On-site work at our Santa Clara location supports clinical trials and market entry efforts. The ideal candidate has a minimum of three years in regulatory affairs, with experience in 510(k)/PMA processes or EU regulations, and strong communication to coordinate

Qualifications

• Bachelor's degree or equivalent education/work experience.
• Minimum 3 years' related regulatory experience.
• Experience with either 510(k), IDE supplements, PMA supplements and US device regulations or with EU and other international medical device regulations.

Responsibilities

• Prepare regulatory submissions for FDA and international agencies.
• Review device labeling and engineering changes for compliance.
• Interface with FDA and other regulatory bodies as needed.
• Support product release and QA systems compliance.
• Maintain up-to-date regulatory knowledge across regions.

Skills

Regulatory experience

FDA guidelines

Regulatory submissions

Team collaboration

Strong communication

Education

Bachelor's degree

Job description

JOB DESCRIPTION:

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 122,000 colleagues serve people in more than 160 countries.

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. You'll also have access to:

• 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.

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.

This Regulatory Affairs Specialist II will work on-site at our Santa Clara, CA location in our Abbott Structural Heart division to perform regulatory activities for a transcatheter heart valve replacement device.

The Opportunity

As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory approval, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for clinical trial operations and product market entry.

What You'll Work On

• Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
• Creates, reviews and approves engineering changes.
• Reviews and provides input on device labeling.
• Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
• Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
• Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• May interface directly with FDA and other regulatory agencies.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• Reviews protocols and reports to support regulatory submissions.
• Supports 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.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor's Degree or an equivalent combination of education and work experience
• Minimum 3 years' related experience, including a minimum of two years regulatory experience
• Experience with either 510(k) applications, IDE supplements, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage, manage and/or engage others to accomplish projects.
• Strong problem-solving skills and ability to think strategically and see the big picture.
• Adaptable with the ability to switch priorities and accomplish all tasks.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Strong organizational and follow-up skills, as well as attention to detail.
• Multitasks, prioritizes and meets deadlines in timely manner.

Preferred Qualifications

Bachelor's Degree in a Sc