Regulatory Affairs Specialist
Job Location:
Pleasanton, CA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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.Youllalso 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 theFreedom 2 Savestudent debtprogramandFreeUeducation benefit - an affordable and convenient path to getting a bachelors degree
A company recognized asa great placeto 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 mission is to help people with heart failure survive and thrive. At Abbotts Heart Failure (HF) business we pioneer and increase access to lifesaving connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis tomonitoringand treatment.
The Opportunity
ThisRegulatory Affairs Specialistwill work out of our Pleasanton CA location in the Heart Failure Division. As an individual contributorinthe function of a Regulatory Affairs Specialist you will provide support to the Regulatory Affairs department. With limitedsupervisionyou will execute tasks and partner across business functions.
As an individual contributor the Regulatory Affairs Specialist will support productregistrationand regulatory activities.
WhatYoullWork On
Asaprofessional in the Regulatory Affairs Sub-Functionpossessesdevelopingskills in product registration submissionchange ordermanagementprogress reports.
Interacts withregulatory affairs team members andothercross functional team membersforregulatory submissions productlicensingandrelevantdocumentation.
Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
Servesasregulatoryliaison throughout product lifecycle.
Ensurestimelyapproval of medical devices and continued approval of marketed products.
May interface with regulatory agencies.
Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
Createsreviewsand approves engineering change orders.
Reviews protocols and reports to support regulatory submissions.
Supports all business segment initiatives asidentifiedby divisional management and in support of Quality Management Systems (QMS) Environmental Management Systems (EMS) and other regulatory requirements
Complies withU.S. Food and Drug Administration (FDA) and international regulations other regulatory requirements Company policies operating procedures processes and task assignments.
Maintainspositive and cooperative communications and collaboration with all levels of employees
Required Qualifications
Bachelors Degree ( 16 years) Technical discipline preferred OR an equivalent combination of education and work experience
No Experience some experience with medical device industry preferred.
Experience working in a broader enterprise/cross-division business unit model preferred. 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 toleverageand/or engage others in accomplishing projects. Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization. Multitasks prioritizes and meets deadlinesin a timely manner. Strong organizational and follow-up skills as well as attention to detail.
Preferred Qualifications
Masters Degree ( 18 years) In science (biology chemistry microbiology immunology medical technology pharmacy pharmacology) math engineering or medical fields is preferred
2 years In a regulated industry (e.g. medical products nutritionals). Regulatoryarea ispreferred but may consider quality assurance research and development/support scientific affairs operations or relatedarea.
Regulatory Knowledge of:
Regulatory history guidelines policies standards practicesrequirementsand precedents.
Regulatory agency structureprocessesand key personnel.
Principles and requirements of applicable product laws.
Submission/registrationtypes and requirements.
GxPs (GCPs GLPs GMPs).
Principles and requirementsofpromotionadvertisingand labeling. Note: This knowledge may be developed through tenure in this position.
Communication Skills or Ability to:
Communicate effectively verbally and in writing.
Learn to write and edit technical documents.
Work with cross-functional teams.
Work with people from various disciplines and cultures.
Cognitive Skills or Ability to:
Pay strong attention to detail.
Handle detailed tasks and prioritize them.
Meetdeadlines.
Think analytically and critically.
Review and analyze documentation.
Research andlocateinformation on regulatory requirements and products.
Exercise judgment within defined procedures and practices to determine appropriate action.
Has general knowledge of technical alternatives andgainan understanding of their impact on the systems environment.
Apply business ethical standards.
The base pay for this position is
$73900.00 $116000.00In specific locations the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
IC
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
