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 115,000 colleagues serve people in more than 160 countries.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people\xe2\x80\x99s health. We\xe2\x80\x99re 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. You\xe2\x80\x99ll 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

student debt program and education benefit - an affordable and convenient path to getting a bachelor\xe2\x80\x99s 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.

Our location in Temecula, CA currently has an opportunity for a Senior Product Performance Clinical Analyst.

The Opportunity

Medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine \xef\xac\x81ngersticks. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

WHAT YOU\'LL DO

Primary Job Function

Analyzes customer complaints to determine which are regulatory reportable and is a key contact for activities with internal, field, and end use customers. Internal resource for clinical interpretation of reported complaints. Responsible for adherence to, and interpretation and implementation of, Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.

Core Job Responsibilities

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

1. Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.;

2. Serves as internal consultant on clinical issues, field actions, and report decision-making. External government contact person, in addition to writing, reviewing, and auditing departmental Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.;

3. Is an expert in cath lab protocol/product application. Evaluates identified complaints. Investigates complaints and provides reporting justifications based on clinical catheter lab experience.

by interpreting clinical outcomes and the devices relationship. Developing clinical lines of questioning for complex complaints to gather sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis. Department mentor/trainer.;

4. Clinical subject matter expert for strategies for regulatory reporting relating clinical cath lab product knowledge and experience. Drives and sets policy for regulatory reporting decisions using event investigation and regulatory decision models. Writes and develops these decision models with changes in product advances/therapies to uphold consistent compliance with government mandated regulations.;

5. Develops and delivers presentations to global regulatory agencies. Topics may include regulatory reporting strategies, compliance issues, or new initiatives such as Global Harmonization. Coordinate Abbott Vascular comments on proposed regulations.;

6. Apply codes and determines new coding on events to facilitate product performance records. Reviews written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.

7. Writes and communicates position papers pertaining to clinical perspective for regulatory reporting, performing literature research, consulting with outside clinical resources to ensure pertinent information is properly disseminated.

(Supervision Received) Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long- term perspective, for desired results.;

(Supervision Provided) May provide work direction and guidance to exempt and/or skilled nonexempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.

Position Accountability / Scope (Influence/Leadership) Understands business environment and relates extensive knowledge of internal and external activities to trends. Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units. Participates in the development of others by facilitating training and providing feedback and guidance. May lead a project team. Provides technical leadership to business units. Acts as a mentor to less-experienced staff. Exercises judgment independently.;

(Planning/Organization) Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project milestones. Establishes priorities of individual or project assignments.;

(Decision Making/Impact) Selects methods and techniques to lead a project to completion. Erroneous decisions or recommendations would typically result in failure to achieve organizational objectives

Minimum Experience / Training Required

Minimum Education

Bachelor\'s degree (Nursing)/(RN) plus 9+ years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.

Minimum Experience / Training Required

• Cath Lab Experience is required (minimum of 2+ years)

(Technical/Business Knowledge (Job Skills)) Comprehensive knowledge and application business concepts, procedures and practices. Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships. Is recognized as an expert in work group. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.;

(Cognitive Skills) Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business.

WHAT WE OFFER :

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

• 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:

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 , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

The salary for this role is between $71,300 \xe2\x80\x93 $142,700

Abbott