Senior Regulatory Specialist

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

ThisSenior Regulatory Affairs Specialistwill work out of our Pleasanton CA location in theHeart FailureDivision. As an individual contributorinthe function of a Sr. 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 Senior Regulatory Affairs Specialist will support product development and regulatory activities.

WhatYoullWork On
As the Experienced professional in the Regulatory Affairs Sub-Functionpossesseswell developed skills in directing development of product registration submission progress reports supplements amendments or periodic experience reports.
Interacts withFDA and otherregulatory agency toexpediteapproval of pending registration.
Serves asregulatoryliaison throughout product lifecycle.
Participatesin some of the following: product plan development and implementation regulatory strategy risk management
Ensurestimelyapproval ofmedical devices and continued approval of marketed products.

Interfaces directly with FDA and other regulatory agencies.

Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.

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 Companypolicies operating procedures processes and task assignments. Maintains positive and cooperative communications andcollaboration with all levels of employees customers contractors and vendors.
Serves as regulatory representative to marketing researchteamsand regulatory agencies.
Advises development and/or marketing teams on manufacturing changes line extensions technical labelingappropriate regulationsand interpretations.

Required Qualifications

• BachelorsDegree ( 16 years) Technical discipline highlypreferredOR an equivalent combination ofeducation and work experience

• Minimum 5 yearsTechnicalexperience including at least 4 years of regulatory experience in a medicaldevice industry.

• Experience with 510(k) applications PMAsupplementsand US device regulations and/or

• experience with EU and other international medical device regulations and submissions.

• 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 changingenvironment.

• Ability toleverageand/or engage othersto accomplishprojects.

• Strong verbal and written communication withabilityto effectively communicate at multiple levels in theorganization.

• Multitasksprioritizesand meets deadlines intimelymanner.

• Strongorganizationand follow-up skills as well as attention to detail.

• Ability to travel approximately 5% includinginternationally.

Preferred Qualifications

• MastersDegree ( 18 years) In Regulatory Affairs preferred and may be used in lieu of direct regulatory3 years 3-4years experiencein a regulated industry (e.g. medical productsnutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance research and development/support scientific affairs operations or relatedarea. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

• Experience with review of labeling promotional and or advertising materials is highly desired

• Familiar withPrinciples and requirements ofpromotionadvertisingand labeling.

• Office program skillsto includeWord Excel PowerPoint AdobeAcrobatand SharePoint.

• Bachelors degree in science (biology chemistry microbiology immunology medical technology pharmacy pharmacology) regulatory affairs engineering or medical fields.Masters Degree in Regulatory Affairs and may be used in lieu of direct regulatory experience.