Regulatory Operations Specialist - Medical Devices

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.

     

JOB DESCRIPTION:

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 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.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies 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 fingersticks.

The Opportunity

We are currently hiring a Regulatory Operations Specialist to work out of our Temecula or Santa Clara, CA office. This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications.  Additionally, 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 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 or work experience.  
·  Minimum 3 years related work 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 and/or engage others to accomplish projects.       
·  Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. 
·  Multitasks, prioritizes and meets deadlines in timely manner.
·  Strong organizational and follow-up skills, as well as attention to detail.        

Preferred   Qualifications

·  Bachelor’s Degree in a technical discipline
·  Experience working in a broader enterprise/cross-division business unit model.
·  Comfortable communicating and presenting in front room audits.

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.

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.

     

The base pay for this position is
$57,300.00 – $114,700.00

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

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

MD Medical Devices

        

LOCATION:

United States > Temecula : 41093 County Center Drive

     

ADDITIONAL LOCATIONS:

United States > Santa Clara : Building A - SC

     

WORK SHIFT:

Standard

     

TRAVEL:

No

     

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