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

Abbot; Santa Clara (CA); On-site; USD 82,000 - 141,000; Full time

Job summary

Abbott in Santa Clara, CA, is seeking a Regulatory Affairs Specialist II to perform regulatory activities for a transcatheter heart valve device. You will work onsite, preparing submissions for FDA and international agencies, supporting clinical trials, and ensuring compliance across regions.

The role requires a Bachelor’s degree and at least 3 years of regulatory experience, with strong communication, organization, and teamwork skills. Master’s degree and regulatory certifications are a plus.

Qualifications

• Bachelor’s Degree or an equivalent combination of education and work experience.
• Minimum 3 years’ related experience, including regulatory experience.
• Experience with 510(k) applications, IDE supplements, PMA supplements or EU/other international medical device regulations and submissions.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong problem-solving, communication and organizational skills.

Responsibilities

• Prepares robust regulatory applications for FDA and international agencies.
• Creates, reviews and approves engineering changes.
• Reviews and provides input on device labeling.
• Acts as a core team member reviewing regulatory guidelines and assessments.
• Reviews communications to ensure regulatory compliance and clarity for global affiliates.
• Maintains up-to-date domestic and international medical device regulations in submission systems.
• Interface with FDA and other regulatory agencies as needed.
• Supports product release by creating licenses or approving release requests.
• Reviews protocols and reports to support regulatory submissions.
• Supports Quality Management Systems, EMS, and other regulatory requirements.

Skills

Regulatory submissions

Cross-functional collaboration

Regulatory knowledge

Attention to detail

Education

Bachelor’s Degree

Master’s degree (preferred)

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 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.

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 $81,500.00 – $141,300.00. In specific locations, the pay range may vary from the range posted.