Regulatory Affairs Specialist Ii – Heart Failure

3+ years

$79,500.00 – $138,700.00

Pleasanton

10 March 10, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Affairs Specialist II – Heart Failure
Location: United States - California - Pleasanton
Category: Regulatory Affairs

About Abbott:
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 114,000 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.
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 obtaining 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 by Fortune.
Recognition 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.

This Regulatory Affairs Specialist II will work out of our Pleasanton, CA location in our Heart Failure Division. In Abbott’s Heart Failure (HF) business, we develop solutions to diagnose, monitor, and manage heart failure, allowing people to restore their health and get on with their lives.

The Opportunity:

As an individual contributor, this position performs specialized work assignments and/or analyses, evaluation, preparation, and submission of documentation for worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for 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.
Acts as a core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
Reviews and evaluates communications to ensure they convey all necessary details and adhere to applicable regulatory standards, including those set by the FDA or other worldwide regulatory agencies.
Maintains pertinent domestic and international medical device regulations to ensure worldwide submission requirements are current, up to date, and entered into the regulatory submission database and file systems.
Ensures that information on such regulations and requirements, especially those that are new or modified, is 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 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, PMA supplements, and US device regulations or with EU and other international medical device regulations and submissions.
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, manage, and/or engage others to accomplish projects.
Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to multitask, prioritize, and meet deadlines in a timely manner.

Preferred Qualifications:

Bachelor’s Degree in a Science/Technical discipline (engineering, life sciences, mathematics).
Master’s degree.
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.

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 and @AbbottGlobal.

Salary Range:
The base pay for this position is $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted.

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Regulatory Affairs Specialist Ii – Heart Failure

Job Description

Working at Abbott:

The Opportunity:

What You’ll Work On:

Required Qualifications:

Preferred Qualifications:

Apply Now:

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