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

1030 Abbott Cardiovascular Sys Inc

California

On-site

USD 82,000 - 141,000

Full time

3 days ago

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Benefits offered by this job

Free medical coverage (HIP PPO)

Excellent retirement plan with high-em

Tuition reimbursement and education

Diversity and inclusion programs

Global career development

Job summary

Abbott is seeking a Regulatory Affairs Specialist II to work on-site in Santa Clara, CA, focusing on regulatory submissions for structural heart devices. You will contribute to FDA and international filings, ensure labeling accuracy, and collaborate with engineering and quality teams.

The role requires strong regulatory knowledge, 3+ years of experience, and the ability to operate in a fast-paced, global environment. Abbott offers comprehensive benefits and career development opportunities.

Qualifications

Bachelor’s Degree or equivalent.
Minimum 3 years’ related experience, including at least 2 years regulatory experience.
Experience with 510(k), IDE supplements, PMA supplements or EU/intl medical device regs.
Ability to work in a team and as an individual contributor in a fast-paced environment.
Strong problem-solving and communication skills; able to adapt to changing priorities.

Responsibilities

Prepare robust regulatory applications for FDA and international regulators.
Review and approve engineering changes and device labeling.
Interface with FDA and other regulatory agencies as needed.
Support regulatory activities for clinical trials and product market entry.
Maintain up-to-date knowledge of domestic/international medical device regulations and submissions.

Skills

Regulatory knowledge

Verbal & written communication

Team contribution

Problem solving

Adaptability

Education

Bachelor’s Degree or equivalent (Regulatory or Science)

Master’s degree (preferred)

Science/Technical discipline

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.

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.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Structural Heart Business Mission

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.

Role Overview

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.

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 Science/Technical discipline (engineering, life sciences, mathematics).
Master’s degree.
Experience with regulatory activities required for clinical trials.
Experience working in a broader enterprise/cross-division business unit model.
Experience working in the Medical Device industry.
Regulatory Affairs Professionals Society Certification is a plus.

Compensation

The base pay for this position is $81,500.00 – $141,300.00 In specific locations, the pay range may vary from the range posted.

Job Details

JOB FAMILY: Regulatory Operations DIVISION: SH Structural Heart LOCATION: United States > Santa Clara : Building A - SC ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Equal Opportunity Employer

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

About Abbott

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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