Regulatory Affairs Manager – Structural Heart (on-site)

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.

     

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re 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’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.

The Opportunity

We are recruiting for a Regulatory Affairs Manager to join our team on-site in Santa Clara, CA. This new team member will be recognized as an expert and resource in regulatory affairs for domestic and international filings. In addition, provides strategy for protocols and approves product testing protocols and reports, and product approval strategies under the direction of the Regulatory Affairs Director. This individual will support project teams to obtain worldwide regulatory approval or clearance for division products as well as provide regulatory support to ensure compliance with all FDA/CE and international regulatory requirements.

What You’ll Work On

• Serve as a mentor for Regulatory Affairs Coordinators, Specialists, and others.
• Develop global regulatory strategies for new and modified products.
• Participate in and provide input to project teams to assure that FDA and international product registrations and licensing applications (original submission and subsequent product enhancements).
• Prepare and submit PMA, IDE, 510(k) and international product registrations and licensing applications (original submission and subsequent product enhancements).
• Maintains a professional demeanor and technical expertise through familiarity with the literature, attendance at professional meetings and participation in team meetings.
• Interpret new or existing regulatory requirements as they relate to division products and procedures.
• Review and advise on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations.

Required Qualifications

• Bachelor’s Degree or an equivalent combination of education and experience
• 3 years’ RA experience, including oversight of submissions for new products and product changes in the health care industry and/or medical devices industry plus at least 1 years in an RA project management role.  Some of the required 3 years overall RA experience can be substituted with experience in a scientific/technical role in the health care industry and/or medical devices industry.
• Leadership competency including organizational development and project management skills.
• Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies.

Preferred Qualifications

• Bachelor’s degree in scientific or engineering related disciplines.
• Advanced degree or additional professional training in regulatory affairs (RA)
• 5 years’ experience in Medical Device industry.
• Think analytically with good problem-solving skills.
• 510(k), PMA, or other international regulatory submission experience.
• Ability to work in a highly matrixed and geographically diverse environment.
• Has broad knowledge of various technical alternatives and their potential impact on the business.
• Exercise good and ethical judgment within policy and regulations.
• Use in-depth knowledge of business functions and cross group dependencies/ relationships.
• Define regulatory strategy with supervision.
• Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Apply Now

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

$112,000.00 – $224,000.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

SH Structural Heart

        

LOCATION:

United States > Santa Clara : Building A - SC

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % 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)

     

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

Salary : $112,000 - $224,000